What influences a trainee’s decision to choose pediatric dermatology as a career?

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– Three factors that may encourage trainees to pursue a career in pediatric dermatology include early exposure to the subspecialty during medical school, mentorship by a board-certified pediatric dermatologist at the trainee’s home institution, and increased salary benefits during and after fellowship.

Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.

Dr. Lucia Z. Diaz

According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.

“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”

For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.

Doug Brunk/MDedge News
Dr. Courtney N. Haller, left, and Dr. Lucia Z. Diaz

In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).

In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).

“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”

The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.



Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).

In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).

Dr. Adelaide A. Hebert


Adelaide A. Hebert, MD, who was asked to comment on the study, said that the lack of salary benefit from additional training is a sticking point for many fellows. “The market trends of supply and demand do not work in pediatric dermatology,” said Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. “You would think that, because there are fewer of us, we should be paid more, but it does not work that way.”

She characterized the overall study findings as “a real testament to what the challenges are” in recruiting trainees to pediatric dermatology. “The influence of mentors resonates in this assessment, but influences that are somewhat beyond our control also play a role, such as lack of salary benefit from additional training, interest in seeing adult patients, and financial factors.”

Neither the researchers nor Dr. Hebert reported having relevant financial disclosures.

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– Three factors that may encourage trainees to pursue a career in pediatric dermatology include early exposure to the subspecialty during medical school, mentorship by a board-certified pediatric dermatologist at the trainee’s home institution, and increased salary benefits during and after fellowship.

Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.

Dr. Lucia Z. Diaz

According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.

“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”

For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.

Doug Brunk/MDedge News
Dr. Courtney N. Haller, left, and Dr. Lucia Z. Diaz

In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).

In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).

“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”

The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.



Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).

In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).

Dr. Adelaide A. Hebert


Adelaide A. Hebert, MD, who was asked to comment on the study, said that the lack of salary benefit from additional training is a sticking point for many fellows. “The market trends of supply and demand do not work in pediatric dermatology,” said Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. “You would think that, because there are fewer of us, we should be paid more, but it does not work that way.”

She characterized the overall study findings as “a real testament to what the challenges are” in recruiting trainees to pediatric dermatology. “The influence of mentors resonates in this assessment, but influences that are somewhat beyond our control also play a role, such as lack of salary benefit from additional training, interest in seeing adult patients, and financial factors.”

Neither the researchers nor Dr. Hebert reported having relevant financial disclosures.

– Three factors that may encourage trainees to pursue a career in pediatric dermatology include early exposure to the subspecialty during medical school, mentorship by a board-certified pediatric dermatologist at the trainee’s home institution, and increased salary benefits during and after fellowship.

Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.

Dr. Lucia Z. Diaz

According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.

“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”

For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.

Doug Brunk/MDedge News
Dr. Courtney N. Haller, left, and Dr. Lucia Z. Diaz

In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).

In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).

“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”

The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.



Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).

In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).

Dr. Adelaide A. Hebert


Adelaide A. Hebert, MD, who was asked to comment on the study, said that the lack of salary benefit from additional training is a sticking point for many fellows. “The market trends of supply and demand do not work in pediatric dermatology,” said Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. “You would think that, because there are fewer of us, we should be paid more, but it does not work that way.”

She characterized the overall study findings as “a real testament to what the challenges are” in recruiting trainees to pediatric dermatology. “The influence of mentors resonates in this assessment, but influences that are somewhat beyond our control also play a role, such as lack of salary benefit from additional training, interest in seeing adult patients, and financial factors.”

Neither the researchers nor Dr. Hebert reported having relevant financial disclosures.

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Uveitis in juvenile arthritis patients persists into midlife

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Changed
Wed, 07/13/2022 - 16:00

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

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Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

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Addressing posttraumatic stress disorder in children and adolescents

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Luke is a 12-year-old who presents for a well-child visit accompanied by his foster mother. He appears more solemn and taciturn than at previous visits. He is not interested in talking about any topics, including things he enjoys. His foster mother states that he has been more irritable, oppositional, and behaviorally dysregulated over the past 2 months. She also notes that his sleep has been poor. He reports this is because of nightmares and trouble falling asleep. Luke states that he will at times remember seeing his mother being struck by his father and – even when he does not want to – will have thoughts about hiding from his dad after being hit. You learn from the foster mother that he has been residing with her for the past 2 months and that he is now in state custody following significant parental home substance use, witnessing domestic violence, and being physically abused by his father.

The above narrative may sound all too familiar to those in pediatric primary care. You may wonder if there is a potential posttraumatic response to the witnessed trauma, but does the patient meet criteria for a trauma-related disorder? If so, what are the best next steps?
 

Prevalence of posttraumatic stress disorder in the general pediatric population

According to the 2020 National Survey of Children’s Health, approximately 40% of children age 17 and under report experiencing at least one adverse childhood experience. Within the 12-17 age range, it rises to over 50%.1 Adverse childhood experiences (ACEs) are potentially traumatic events and include items such as experiencing violence/abuse/neglect, witnessing violence in the home or community, having a family member attempt or die by suicide, and other adverse household and environmental situations. The accumulation of these ACEs can lead to long-term adverse emotional, physical, and behavioral outcomes.2

Dr. Yasmeen Abdul-Karim, University of Vermont, Burlington
Dr. Yasmeen Abdul-Karim

However, adverse childhood experiences do not always translate into PTSD. According to one national survey of 13- to 18-year-olds, the lifetime prevalence of PTSD is notably lower than exposure rates to ACEs and is estimated at 5% of adolescents, with higher rates among females (8%) versus males (2.3%).3

There are various risk factors for the development of PTSD that may play a role including genetic vulnerability, length of the trauma (for example, a one-time event versus repeated trauma for years), characteristics specific to the trauma, and the aftermath of the trauma. Again, it is important to note that not all youth exposed to a traumatic event will develop PTSD. Those who do make up a small percentage of at-risk children.4
 

Diagnosing PTSD in a child or adolescent

For a pediatric patient to be diagnosed with PTSD according to the DSM-5 criteria, they must experience a potentially traumatic event and meet criteria from four categories of symptoms. Trauma is defined as direct or indirect exposure to actual or threatened death, serious injury, or sexual violence. The four symptom categories are re-experiencing, avoidance, hyperarousal, and negative alteration in cognition and mood. The number of symptoms needed from each category varies based on the child’s age, with differing cutoffs based on whether the child is younger or older than 6 years old. Moreover, symptoms must be present for at least 1 month.5

 

 

Trauma can be assessed in the office by using a focused interview that includes the full DSM diagnostic criteria. There are additional trauma rating screeners and assessment tools that can be used including the Child PTSD Symptom Scale, Child Trauma Screening Questionnaire, UCLA Posttraumatic Stress Disorder Reaction Index, and the Trauma Symptom Checklist for Children, to name a few. Many of these allow for multiple informants, including the child/adolescent, thereby allowing for varying perspectives regarding trauma reactions.
 

Treatment options

Familiarity with evidence-based treatment for trauma may be useful to ensure that referral is targeted for the patient/family. There are no Food and Drug Administrations–approved medications for children with PTSD, though medications can be used to target specific PTSD symptoms (e.g. prazosin for trauma-related nightmares) as well as commonly comorbid conditions such as depression. Becoming familiar with the available therapeutic modalities offered in your area is recommended.

Highlighting trauma-focused cognitive behavioral therapy (TF-CBT)

The treatment with the most research evidence for traumatized children is trauma-focused cognitive behavioral therapy (TF-CBT), which is a 12- to 25-session therapeutic intervention for patients 3-18 years old (with some evidence for young adults as well) with PTSD and/or trauma-related behaviors. TF-CBT uses a components-based treatment model encompassed by the PRACTICE acronym/mnemonic.6,7

  • P – Psychoeducation and parenting skills.
  • R – Relaxation techniques: Focused breathing, progressive muscle relaxation, and teaching the child to control their thoughts (thought stopping).
  • A – Affective expression and regulation (feeling identification): To help the child and parent learn to control their emotional reaction to reminders by expanding their emotional vocabulary, enhancing their skills in identification and expression of emotions, and encouraging self-soothing activities
  • C – Cognitive coping and processing: Through this component, the child learns to understand the relationships between thoughts, feelings, and behaviors and think in new and healthier ways.
  • T – Trauma narrative and processing: Gradual exposure exercises including verbal, written, and/or symbolic recounting of traumatic event(s) so the child learns to be able to discuss the events when they choose to in ways that do not produce overwhelming emotions. Following the completion of the narrative, clients are supported in identifying, challenging, and correcting cognitive distortions and dysfunctional beliefs.
  • I – In vivo exposure: Encourage the gradual exposure to innocuous trauma reminders in the child’s environment so the child learns they can control their emotional reactions to things that remind them of the trauma, starting with nonthreatening examples of reminders.
  • C – Conjoint parent/child sessions: Sessions generally deal with psycho-education, sharing the trauma narrative, anxiety management, and correction of cognitive distortions. The family works to enhance communication and create opportunities for therapeutic discussion regarding the trauma.
  • E – Enhancing personal safety and future growth: Provide training and education with respect to personal safety skills and healthy sexuality and interpersonal relationships; encourage the utilization of skills learned in managing future stressors and/or trauma reminders.

Of note, some elements of this therapy that could possibly be easily incorporated into a primary care office visit include relaxation techniques and focus on coping skills/strategies.
 

Summary

Children and adolescents often present with trauma-related symptoms to the primary care office. Having increasing familiarity with PTSD diagnostic criteria and treatment modalities will likely lead to increased confidence and comfort recognizing symptoms and when placing a referral. This may also lead to shorter wait times for receiving targeted treatment and ultimately should lead to better outcomes for affected children and families.

Dr. Abdul-Kareem is at the University of Vermont, Burlington.

References

1. National Survey of Children’s Health (2016 - present). https://nschdata.org/browse/survey.

2. Adverse Childhood Experiences (ACEs). Centers for Disease Control and Prevention. https://www.cdc.gov/violenceprevention/aces/index.html].

3. Post-Traumatic Stress Disorder (PTSD). National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/post-traumatic-stress-disorder-ptsd,

4. Martin A et al. Lewis’s Child and Adolescent Psychiatry (5th edition). Lippincott Williams & Wilkins: Philadelphia, 2017.

5. American Psychiatric Association. Neurodevelopmental disorders. In: DSM-5.  2013.

6. Trauma-Focused Cognitive Behavioral Therapy. The National Child Traumatic Stress Network. https://www.nctsn.org/interventions/trauma-focused-cognitive-behavioral-therapy.

7. Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT). California Evidence-Based Clearinghouse for Child Welfare. https://www.cebc4cw.org/program/trauma-focused-cognitive-behavioral-therapy/.

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Luke is a 12-year-old who presents for a well-child visit accompanied by his foster mother. He appears more solemn and taciturn than at previous visits. He is not interested in talking about any topics, including things he enjoys. His foster mother states that he has been more irritable, oppositional, and behaviorally dysregulated over the past 2 months. She also notes that his sleep has been poor. He reports this is because of nightmares and trouble falling asleep. Luke states that he will at times remember seeing his mother being struck by his father and – even when he does not want to – will have thoughts about hiding from his dad after being hit. You learn from the foster mother that he has been residing with her for the past 2 months and that he is now in state custody following significant parental home substance use, witnessing domestic violence, and being physically abused by his father.

The above narrative may sound all too familiar to those in pediatric primary care. You may wonder if there is a potential posttraumatic response to the witnessed trauma, but does the patient meet criteria for a trauma-related disorder? If so, what are the best next steps?
 

Prevalence of posttraumatic stress disorder in the general pediatric population

According to the 2020 National Survey of Children’s Health, approximately 40% of children age 17 and under report experiencing at least one adverse childhood experience. Within the 12-17 age range, it rises to over 50%.1 Adverse childhood experiences (ACEs) are potentially traumatic events and include items such as experiencing violence/abuse/neglect, witnessing violence in the home or community, having a family member attempt or die by suicide, and other adverse household and environmental situations. The accumulation of these ACEs can lead to long-term adverse emotional, physical, and behavioral outcomes.2

Dr. Yasmeen Abdul-Karim, University of Vermont, Burlington
Dr. Yasmeen Abdul-Karim

However, adverse childhood experiences do not always translate into PTSD. According to one national survey of 13- to 18-year-olds, the lifetime prevalence of PTSD is notably lower than exposure rates to ACEs and is estimated at 5% of adolescents, with higher rates among females (8%) versus males (2.3%).3

There are various risk factors for the development of PTSD that may play a role including genetic vulnerability, length of the trauma (for example, a one-time event versus repeated trauma for years), characteristics specific to the trauma, and the aftermath of the trauma. Again, it is important to note that not all youth exposed to a traumatic event will develop PTSD. Those who do make up a small percentage of at-risk children.4
 

Diagnosing PTSD in a child or adolescent

For a pediatric patient to be diagnosed with PTSD according to the DSM-5 criteria, they must experience a potentially traumatic event and meet criteria from four categories of symptoms. Trauma is defined as direct or indirect exposure to actual or threatened death, serious injury, or sexual violence. The four symptom categories are re-experiencing, avoidance, hyperarousal, and negative alteration in cognition and mood. The number of symptoms needed from each category varies based on the child’s age, with differing cutoffs based on whether the child is younger or older than 6 years old. Moreover, symptoms must be present for at least 1 month.5

 

 

Trauma can be assessed in the office by using a focused interview that includes the full DSM diagnostic criteria. There are additional trauma rating screeners and assessment tools that can be used including the Child PTSD Symptom Scale, Child Trauma Screening Questionnaire, UCLA Posttraumatic Stress Disorder Reaction Index, and the Trauma Symptom Checklist for Children, to name a few. Many of these allow for multiple informants, including the child/adolescent, thereby allowing for varying perspectives regarding trauma reactions.
 

Treatment options

Familiarity with evidence-based treatment for trauma may be useful to ensure that referral is targeted for the patient/family. There are no Food and Drug Administrations–approved medications for children with PTSD, though medications can be used to target specific PTSD symptoms (e.g. prazosin for trauma-related nightmares) as well as commonly comorbid conditions such as depression. Becoming familiar with the available therapeutic modalities offered in your area is recommended.

Highlighting trauma-focused cognitive behavioral therapy (TF-CBT)

The treatment with the most research evidence for traumatized children is trauma-focused cognitive behavioral therapy (TF-CBT), which is a 12- to 25-session therapeutic intervention for patients 3-18 years old (with some evidence for young adults as well) with PTSD and/or trauma-related behaviors. TF-CBT uses a components-based treatment model encompassed by the PRACTICE acronym/mnemonic.6,7

  • P – Psychoeducation and parenting skills.
  • R – Relaxation techniques: Focused breathing, progressive muscle relaxation, and teaching the child to control their thoughts (thought stopping).
  • A – Affective expression and regulation (feeling identification): To help the child and parent learn to control their emotional reaction to reminders by expanding their emotional vocabulary, enhancing their skills in identification and expression of emotions, and encouraging self-soothing activities
  • C – Cognitive coping and processing: Through this component, the child learns to understand the relationships between thoughts, feelings, and behaviors and think in new and healthier ways.
  • T – Trauma narrative and processing: Gradual exposure exercises including verbal, written, and/or symbolic recounting of traumatic event(s) so the child learns to be able to discuss the events when they choose to in ways that do not produce overwhelming emotions. Following the completion of the narrative, clients are supported in identifying, challenging, and correcting cognitive distortions and dysfunctional beliefs.
  • I – In vivo exposure: Encourage the gradual exposure to innocuous trauma reminders in the child’s environment so the child learns they can control their emotional reactions to things that remind them of the trauma, starting with nonthreatening examples of reminders.
  • C – Conjoint parent/child sessions: Sessions generally deal with psycho-education, sharing the trauma narrative, anxiety management, and correction of cognitive distortions. The family works to enhance communication and create opportunities for therapeutic discussion regarding the trauma.
  • E – Enhancing personal safety and future growth: Provide training and education with respect to personal safety skills and healthy sexuality and interpersonal relationships; encourage the utilization of skills learned in managing future stressors and/or trauma reminders.

Of note, some elements of this therapy that could possibly be easily incorporated into a primary care office visit include relaxation techniques and focus on coping skills/strategies.
 

Summary

Children and adolescents often present with trauma-related symptoms to the primary care office. Having increasing familiarity with PTSD diagnostic criteria and treatment modalities will likely lead to increased confidence and comfort recognizing symptoms and when placing a referral. This may also lead to shorter wait times for receiving targeted treatment and ultimately should lead to better outcomes for affected children and families.

Dr. Abdul-Kareem is at the University of Vermont, Burlington.

References

1. National Survey of Children’s Health (2016 - present). https://nschdata.org/browse/survey.

2. Adverse Childhood Experiences (ACEs). Centers for Disease Control and Prevention. https://www.cdc.gov/violenceprevention/aces/index.html].

3. Post-Traumatic Stress Disorder (PTSD). National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/post-traumatic-stress-disorder-ptsd,

4. Martin A et al. Lewis’s Child and Adolescent Psychiatry (5th edition). Lippincott Williams & Wilkins: Philadelphia, 2017.

5. American Psychiatric Association. Neurodevelopmental disorders. In: DSM-5.  2013.

6. Trauma-Focused Cognitive Behavioral Therapy. The National Child Traumatic Stress Network. https://www.nctsn.org/interventions/trauma-focused-cognitive-behavioral-therapy.

7. Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT). California Evidence-Based Clearinghouse for Child Welfare. https://www.cebc4cw.org/program/trauma-focused-cognitive-behavioral-therapy/.

Luke is a 12-year-old who presents for a well-child visit accompanied by his foster mother. He appears more solemn and taciturn than at previous visits. He is not interested in talking about any topics, including things he enjoys. His foster mother states that he has been more irritable, oppositional, and behaviorally dysregulated over the past 2 months. She also notes that his sleep has been poor. He reports this is because of nightmares and trouble falling asleep. Luke states that he will at times remember seeing his mother being struck by his father and – even when he does not want to – will have thoughts about hiding from his dad after being hit. You learn from the foster mother that he has been residing with her for the past 2 months and that he is now in state custody following significant parental home substance use, witnessing domestic violence, and being physically abused by his father.

The above narrative may sound all too familiar to those in pediatric primary care. You may wonder if there is a potential posttraumatic response to the witnessed trauma, but does the patient meet criteria for a trauma-related disorder? If so, what are the best next steps?
 

Prevalence of posttraumatic stress disorder in the general pediatric population

According to the 2020 National Survey of Children’s Health, approximately 40% of children age 17 and under report experiencing at least one adverse childhood experience. Within the 12-17 age range, it rises to over 50%.1 Adverse childhood experiences (ACEs) are potentially traumatic events and include items such as experiencing violence/abuse/neglect, witnessing violence in the home or community, having a family member attempt or die by suicide, and other adverse household and environmental situations. The accumulation of these ACEs can lead to long-term adverse emotional, physical, and behavioral outcomes.2

Dr. Yasmeen Abdul-Karim, University of Vermont, Burlington
Dr. Yasmeen Abdul-Karim

However, adverse childhood experiences do not always translate into PTSD. According to one national survey of 13- to 18-year-olds, the lifetime prevalence of PTSD is notably lower than exposure rates to ACEs and is estimated at 5% of adolescents, with higher rates among females (8%) versus males (2.3%).3

There are various risk factors for the development of PTSD that may play a role including genetic vulnerability, length of the trauma (for example, a one-time event versus repeated trauma for years), characteristics specific to the trauma, and the aftermath of the trauma. Again, it is important to note that not all youth exposed to a traumatic event will develop PTSD. Those who do make up a small percentage of at-risk children.4
 

Diagnosing PTSD in a child or adolescent

For a pediatric patient to be diagnosed with PTSD according to the DSM-5 criteria, they must experience a potentially traumatic event and meet criteria from four categories of symptoms. Trauma is defined as direct or indirect exposure to actual or threatened death, serious injury, or sexual violence. The four symptom categories are re-experiencing, avoidance, hyperarousal, and negative alteration in cognition and mood. The number of symptoms needed from each category varies based on the child’s age, with differing cutoffs based on whether the child is younger or older than 6 years old. Moreover, symptoms must be present for at least 1 month.5

 

 

Trauma can be assessed in the office by using a focused interview that includes the full DSM diagnostic criteria. There are additional trauma rating screeners and assessment tools that can be used including the Child PTSD Symptom Scale, Child Trauma Screening Questionnaire, UCLA Posttraumatic Stress Disorder Reaction Index, and the Trauma Symptom Checklist for Children, to name a few. Many of these allow for multiple informants, including the child/adolescent, thereby allowing for varying perspectives regarding trauma reactions.
 

Treatment options

Familiarity with evidence-based treatment for trauma may be useful to ensure that referral is targeted for the patient/family. There are no Food and Drug Administrations–approved medications for children with PTSD, though medications can be used to target specific PTSD symptoms (e.g. prazosin for trauma-related nightmares) as well as commonly comorbid conditions such as depression. Becoming familiar with the available therapeutic modalities offered in your area is recommended.

Highlighting trauma-focused cognitive behavioral therapy (TF-CBT)

The treatment with the most research evidence for traumatized children is trauma-focused cognitive behavioral therapy (TF-CBT), which is a 12- to 25-session therapeutic intervention for patients 3-18 years old (with some evidence for young adults as well) with PTSD and/or trauma-related behaviors. TF-CBT uses a components-based treatment model encompassed by the PRACTICE acronym/mnemonic.6,7

  • P – Psychoeducation and parenting skills.
  • R – Relaxation techniques: Focused breathing, progressive muscle relaxation, and teaching the child to control their thoughts (thought stopping).
  • A – Affective expression and regulation (feeling identification): To help the child and parent learn to control their emotional reaction to reminders by expanding their emotional vocabulary, enhancing their skills in identification and expression of emotions, and encouraging self-soothing activities
  • C – Cognitive coping and processing: Through this component, the child learns to understand the relationships between thoughts, feelings, and behaviors and think in new and healthier ways.
  • T – Trauma narrative and processing: Gradual exposure exercises including verbal, written, and/or symbolic recounting of traumatic event(s) so the child learns to be able to discuss the events when they choose to in ways that do not produce overwhelming emotions. Following the completion of the narrative, clients are supported in identifying, challenging, and correcting cognitive distortions and dysfunctional beliefs.
  • I – In vivo exposure: Encourage the gradual exposure to innocuous trauma reminders in the child’s environment so the child learns they can control their emotional reactions to things that remind them of the trauma, starting with nonthreatening examples of reminders.
  • C – Conjoint parent/child sessions: Sessions generally deal with psycho-education, sharing the trauma narrative, anxiety management, and correction of cognitive distortions. The family works to enhance communication and create opportunities for therapeutic discussion regarding the trauma.
  • E – Enhancing personal safety and future growth: Provide training and education with respect to personal safety skills and healthy sexuality and interpersonal relationships; encourage the utilization of skills learned in managing future stressors and/or trauma reminders.

Of note, some elements of this therapy that could possibly be easily incorporated into a primary care office visit include relaxation techniques and focus on coping skills/strategies.
 

Summary

Children and adolescents often present with trauma-related symptoms to the primary care office. Having increasing familiarity with PTSD diagnostic criteria and treatment modalities will likely lead to increased confidence and comfort recognizing symptoms and when placing a referral. This may also lead to shorter wait times for receiving targeted treatment and ultimately should lead to better outcomes for affected children and families.

Dr. Abdul-Kareem is at the University of Vermont, Burlington.

References

1. National Survey of Children’s Health (2016 - present). https://nschdata.org/browse/survey.

2. Adverse Childhood Experiences (ACEs). Centers for Disease Control and Prevention. https://www.cdc.gov/violenceprevention/aces/index.html].

3. Post-Traumatic Stress Disorder (PTSD). National Institute of Mental Health. https://www.nimh.nih.gov/health/statistics/post-traumatic-stress-disorder-ptsd,

4. Martin A et al. Lewis’s Child and Adolescent Psychiatry (5th edition). Lippincott Williams & Wilkins: Philadelphia, 2017.

5. American Psychiatric Association. Neurodevelopmental disorders. In: DSM-5.  2013.

6. Trauma-Focused Cognitive Behavioral Therapy. The National Child Traumatic Stress Network. https://www.nctsn.org/interventions/trauma-focused-cognitive-behavioral-therapy.

7. Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT). California Evidence-Based Clearinghouse for Child Welfare. https://www.cebc4cw.org/program/trauma-focused-cognitive-behavioral-therapy/.

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Topical gel for epidermolysis bullosa shows ongoing benefit

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Changed
Tue, 07/12/2022 - 15:42

The wound-healing benefits seen with a topical agent containing the bark derivative oleogel-S10 (Filsuvez) for patients with epidermolysis bullosa (EB) continue to accrue with continued use, suggests data from an open-label extension of EASE, the phase 3 safety and efficacy study of the treatment.

Over 200 patients from the trial, including 105 who began treatment with a control gel, continued taking oleogel-S10 after 90 days. The current interim analysis at 12 months indicates there was a 55% reduction in the proportion of the body affected, compared with baseline.

Moreover, reductions in skin activity scores seen in the double-blind phase of the trial were maintained during the open-label extension. About 6% of patients experienced adverse events that led to withdrawal from the study.

The results show that oleogel-S10 was associated with “accelerated wound healing,” said study presenter Tracey Cunningham, MD, chief medical officer, Amryt Pharmaceuticals DAC, Dublin, which is developing the topical agent. “There were no new safety signals with this longer exposure to oleogel-S10, and patients had sustained improvement in wound burden,” she added.

The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 6.

In April, European Medicines Agency recommended approval of oleogel-S10 for the treatment of partial-thickness skin wounds associated with dystrophic and junctional EB for patients aged 6 months and older.

However, just a month earlier, the U.S. Food and Drug Administration declined to approve the topical agent for use in EB, even after it extended its review by 3 months to include additional analyses of data previously submitted by the company.

In the post-presentation discussion, Dr. Cunningham said that the FDA had “not been satisfied at this point with the information that we have given them,” adding, “We don’t agree with the decision, and we will be appealing.”

Raman K. Madan, MD, a dermatologist at Northwell Health, Huntington, New York, who was not involved in the study, said that the reductions in wound healing seen in the study are “meaningful” and that the numbers represent a “big breakthrough.”

He told this news organization that there are “very few products on the market” for EB and that having an option for patients “would be amazing.”

“The big issue here would be cost and coverage for patients,” he said. If approved, “hopefully” it will be affordable, he added.

Dr. Madan noted that from his perspective, the majority of the reactions to the topical gel were “mild,” and there are “a lot of confounding factors” underlying the number of serious adverse events. “These patients with epidermolysis are prone to some of these issues regardless of treatment,” he said.

During her presentation, Dr. Cunningham noted that EB is a rare, debilitating condition that is characterized by varying degrees of skin fragility, blisters, and impaired wound healing that in turn lead to serious complications that affect quality of life.

While wound management is a “fundamental priority” for patients living with EB, she said, there is a “high, unmet” clinical need.



To those ends, EASE was the largest randomized controlled phase 3 efficacy and safety study in EB. In the study, 252 patients were allocated to receive oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing.

The double-blind phase of the trial met its primary endpoint: A higher proportion of patients who were given oleogel-S10 achieved first complete closure of the EB target wound by day 45, compared with patients who were given control gel, at 41.3% versus 28.9%. This equated to a relative risk of wound closure by day 45 of 1.44, or an odds ratio of 1.84 (P = .013).

However, as reported at the time by this news organization, the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of oleogel-S10 patients achieving wound closure, versus 43.9% of those in the control group.

Dr. Cunningham discussed the open-label extension, which involved 205 patients from the double-blind phase (mean age, of 16.3 years) treated with oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing for 24 months.

In presenting the results of the first 12 months of the open-label extension, she said that oleogel-S10 led to “consistent” reductions in the body surface area percentage (BSAP) affected by EB. The overall reduction from baseline was 55% after receiving treatment for 15 months.

Between day 90 and month 12 of the open-label extension, the absolute BSAP was reduced from 7.4% to 5.4% for patients who had received oleogel-S10 from the start of the study. For those who started in the control group and then switched to the oleogel-S10 arm during the open-label extension, the reduction was from 8.3% to 6.4%.

Dr. Cunningham pointed out that a 1% reduction in BSAP equates approximately to the palmar surface of the hand.

Scores on the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) Skin activity subscale indicated that the reductions achieved in the double-blind phase of the trial were maintained.

Among patients who received oleogel-S10 from the start of the trial, EBDASI Skin scores were reduced from 19.6 at baseline to 13.5 at 12 months’ follow-up in the open-label extension. The reduction was from 19.6 to 13.5 for those who began the trial taking control gel.

Dr. Cunningham showed that adverse events of any grade were seen in 72.0% of patients who began taking oleogel-S10 at the start of the trial and in 69.5% of those who began the trial taking control gel.

Serious adverse events were recorded in 23.0% and 20.0% of patients, respectively, while 6.0% of those who initially received oleogel-S10 and 6.7% of those initially assigned to control gel experienced adverse events that led to study withdrawal during the open-label phase.

The most frequently reported adverse events in the open-label extension were wound complications, seen in 39.5% of patients; anemia, seen in 14.1%; wound infection, seen in 9.3%; pyrexia, seen in 8.3%; and pruritus, seen in 5.9%. No more details regarding adverse events were provided.

The study was funded by Amryt Pharmaceuticals DAC. Dr. Cunningham is an employee of Amryt Pharmaceuticals. No other relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

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The wound-healing benefits seen with a topical agent containing the bark derivative oleogel-S10 (Filsuvez) for patients with epidermolysis bullosa (EB) continue to accrue with continued use, suggests data from an open-label extension of EASE, the phase 3 safety and efficacy study of the treatment.

Over 200 patients from the trial, including 105 who began treatment with a control gel, continued taking oleogel-S10 after 90 days. The current interim analysis at 12 months indicates there was a 55% reduction in the proportion of the body affected, compared with baseline.

Moreover, reductions in skin activity scores seen in the double-blind phase of the trial were maintained during the open-label extension. About 6% of patients experienced adverse events that led to withdrawal from the study.

The results show that oleogel-S10 was associated with “accelerated wound healing,” said study presenter Tracey Cunningham, MD, chief medical officer, Amryt Pharmaceuticals DAC, Dublin, which is developing the topical agent. “There were no new safety signals with this longer exposure to oleogel-S10, and patients had sustained improvement in wound burden,” she added.

The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 6.

In April, European Medicines Agency recommended approval of oleogel-S10 for the treatment of partial-thickness skin wounds associated with dystrophic and junctional EB for patients aged 6 months and older.

However, just a month earlier, the U.S. Food and Drug Administration declined to approve the topical agent for use in EB, even after it extended its review by 3 months to include additional analyses of data previously submitted by the company.

In the post-presentation discussion, Dr. Cunningham said that the FDA had “not been satisfied at this point with the information that we have given them,” adding, “We don’t agree with the decision, and we will be appealing.”

Raman K. Madan, MD, a dermatologist at Northwell Health, Huntington, New York, who was not involved in the study, said that the reductions in wound healing seen in the study are “meaningful” and that the numbers represent a “big breakthrough.”

He told this news organization that there are “very few products on the market” for EB and that having an option for patients “would be amazing.”

“The big issue here would be cost and coverage for patients,” he said. If approved, “hopefully” it will be affordable, he added.

Dr. Madan noted that from his perspective, the majority of the reactions to the topical gel were “mild,” and there are “a lot of confounding factors” underlying the number of serious adverse events. “These patients with epidermolysis are prone to some of these issues regardless of treatment,” he said.

During her presentation, Dr. Cunningham noted that EB is a rare, debilitating condition that is characterized by varying degrees of skin fragility, blisters, and impaired wound healing that in turn lead to serious complications that affect quality of life.

While wound management is a “fundamental priority” for patients living with EB, she said, there is a “high, unmet” clinical need.



To those ends, EASE was the largest randomized controlled phase 3 efficacy and safety study in EB. In the study, 252 patients were allocated to receive oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing.

The double-blind phase of the trial met its primary endpoint: A higher proportion of patients who were given oleogel-S10 achieved first complete closure of the EB target wound by day 45, compared with patients who were given control gel, at 41.3% versus 28.9%. This equated to a relative risk of wound closure by day 45 of 1.44, or an odds ratio of 1.84 (P = .013).

However, as reported at the time by this news organization, the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of oleogel-S10 patients achieving wound closure, versus 43.9% of those in the control group.

Dr. Cunningham discussed the open-label extension, which involved 205 patients from the double-blind phase (mean age, of 16.3 years) treated with oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing for 24 months.

In presenting the results of the first 12 months of the open-label extension, she said that oleogel-S10 led to “consistent” reductions in the body surface area percentage (BSAP) affected by EB. The overall reduction from baseline was 55% after receiving treatment for 15 months.

Between day 90 and month 12 of the open-label extension, the absolute BSAP was reduced from 7.4% to 5.4% for patients who had received oleogel-S10 from the start of the study. For those who started in the control group and then switched to the oleogel-S10 arm during the open-label extension, the reduction was from 8.3% to 6.4%.

Dr. Cunningham pointed out that a 1% reduction in BSAP equates approximately to the palmar surface of the hand.

Scores on the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) Skin activity subscale indicated that the reductions achieved in the double-blind phase of the trial were maintained.

Among patients who received oleogel-S10 from the start of the trial, EBDASI Skin scores were reduced from 19.6 at baseline to 13.5 at 12 months’ follow-up in the open-label extension. The reduction was from 19.6 to 13.5 for those who began the trial taking control gel.

Dr. Cunningham showed that adverse events of any grade were seen in 72.0% of patients who began taking oleogel-S10 at the start of the trial and in 69.5% of those who began the trial taking control gel.

Serious adverse events were recorded in 23.0% and 20.0% of patients, respectively, while 6.0% of those who initially received oleogel-S10 and 6.7% of those initially assigned to control gel experienced adverse events that led to study withdrawal during the open-label phase.

The most frequently reported adverse events in the open-label extension were wound complications, seen in 39.5% of patients; anemia, seen in 14.1%; wound infection, seen in 9.3%; pyrexia, seen in 8.3%; and pruritus, seen in 5.9%. No more details regarding adverse events were provided.

The study was funded by Amryt Pharmaceuticals DAC. Dr. Cunningham is an employee of Amryt Pharmaceuticals. No other relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

The wound-healing benefits seen with a topical agent containing the bark derivative oleogel-S10 (Filsuvez) for patients with epidermolysis bullosa (EB) continue to accrue with continued use, suggests data from an open-label extension of EASE, the phase 3 safety and efficacy study of the treatment.

Over 200 patients from the trial, including 105 who began treatment with a control gel, continued taking oleogel-S10 after 90 days. The current interim analysis at 12 months indicates there was a 55% reduction in the proportion of the body affected, compared with baseline.

Moreover, reductions in skin activity scores seen in the double-blind phase of the trial were maintained during the open-label extension. About 6% of patients experienced adverse events that led to withdrawal from the study.

The results show that oleogel-S10 was associated with “accelerated wound healing,” said study presenter Tracey Cunningham, MD, chief medical officer, Amryt Pharmaceuticals DAC, Dublin, which is developing the topical agent. “There were no new safety signals with this longer exposure to oleogel-S10, and patients had sustained improvement in wound burden,” she added.

The research was presented at the British Association of Dermatologists (BAD) 2022 Annual Meeting on July 6.

In April, European Medicines Agency recommended approval of oleogel-S10 for the treatment of partial-thickness skin wounds associated with dystrophic and junctional EB for patients aged 6 months and older.

However, just a month earlier, the U.S. Food and Drug Administration declined to approve the topical agent for use in EB, even after it extended its review by 3 months to include additional analyses of data previously submitted by the company.

In the post-presentation discussion, Dr. Cunningham said that the FDA had “not been satisfied at this point with the information that we have given them,” adding, “We don’t agree with the decision, and we will be appealing.”

Raman K. Madan, MD, a dermatologist at Northwell Health, Huntington, New York, who was not involved in the study, said that the reductions in wound healing seen in the study are “meaningful” and that the numbers represent a “big breakthrough.”

He told this news organization that there are “very few products on the market” for EB and that having an option for patients “would be amazing.”

“The big issue here would be cost and coverage for patients,” he said. If approved, “hopefully” it will be affordable, he added.

Dr. Madan noted that from his perspective, the majority of the reactions to the topical gel were “mild,” and there are “a lot of confounding factors” underlying the number of serious adverse events. “These patients with epidermolysis are prone to some of these issues regardless of treatment,” he said.

During her presentation, Dr. Cunningham noted that EB is a rare, debilitating condition that is characterized by varying degrees of skin fragility, blisters, and impaired wound healing that in turn lead to serious complications that affect quality of life.

While wound management is a “fundamental priority” for patients living with EB, she said, there is a “high, unmet” clinical need.



To those ends, EASE was the largest randomized controlled phase 3 efficacy and safety study in EB. In the study, 252 patients were allocated to receive oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing.

The double-blind phase of the trial met its primary endpoint: A higher proportion of patients who were given oleogel-S10 achieved first complete closure of the EB target wound by day 45, compared with patients who were given control gel, at 41.3% versus 28.9%. This equated to a relative risk of wound closure by day 45 of 1.44, or an odds ratio of 1.84 (P = .013).

However, as reported at the time by this news organization, the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of oleogel-S10 patients achieving wound closure, versus 43.9% of those in the control group.

Dr. Cunningham discussed the open-label extension, which involved 205 patients from the double-blind phase (mean age, of 16.3 years) treated with oleogel-S10 or control gel plus standard-of-care nonadhesive wound dressing for 24 months.

In presenting the results of the first 12 months of the open-label extension, she said that oleogel-S10 led to “consistent” reductions in the body surface area percentage (BSAP) affected by EB. The overall reduction from baseline was 55% after receiving treatment for 15 months.

Between day 90 and month 12 of the open-label extension, the absolute BSAP was reduced from 7.4% to 5.4% for patients who had received oleogel-S10 from the start of the study. For those who started in the control group and then switched to the oleogel-S10 arm during the open-label extension, the reduction was from 8.3% to 6.4%.

Dr. Cunningham pointed out that a 1% reduction in BSAP equates approximately to the palmar surface of the hand.

Scores on the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) Skin activity subscale indicated that the reductions achieved in the double-blind phase of the trial were maintained.

Among patients who received oleogel-S10 from the start of the trial, EBDASI Skin scores were reduced from 19.6 at baseline to 13.5 at 12 months’ follow-up in the open-label extension. The reduction was from 19.6 to 13.5 for those who began the trial taking control gel.

Dr. Cunningham showed that adverse events of any grade were seen in 72.0% of patients who began taking oleogel-S10 at the start of the trial and in 69.5% of those who began the trial taking control gel.

Serious adverse events were recorded in 23.0% and 20.0% of patients, respectively, while 6.0% of those who initially received oleogel-S10 and 6.7% of those initially assigned to control gel experienced adverse events that led to study withdrawal during the open-label phase.

The most frequently reported adverse events in the open-label extension were wound complications, seen in 39.5% of patients; anemia, seen in 14.1%; wound infection, seen in 9.3%; pyrexia, seen in 8.3%; and pruritus, seen in 5.9%. No more details regarding adverse events were provided.

The study was funded by Amryt Pharmaceuticals DAC. Dr. Cunningham is an employee of Amryt Pharmaceuticals. No other relevant financial relationships have been disclosed.

A version of this article first appeared on Medscape.com.

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Children and COVID: Vaccination a harder sell in the summer

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Tue, 07/12/2022 - 15:37

The COVID-19 vaccination effort in the youngest children has begun much more slowly than the most recent rollout for older children, according to the Centers for Disease Control and Prevention.

Almost 263,000 children under age 5 years were vaccinated in the first 2 weeks after final approval on June 18, compared with the over 3 million children aged 5-11 years who received their first dose during the 2 weeks after approval in early November of 2021, based on CDC data last updated on July 7.

That approval, of course, came between the Delta and Omicron surges, when awareness was higher. The low initial uptake among those under age 5, however, was not unexpected by the Biden administration. “That number in and of itself is very much in line with our expectation, and we’re eager to continue working closely with partners to build on this start,” a senior administration official told ABC News.

With approval of the vaccine occurring after the school year was over, parents’ thoughts have been focused more on vacations and less on vaccinations. “Even before these vaccines officially became available, this was going to be a different rollout; it was going to take more time,” the official explained.
 

Incidence measures continue on different paths

New COVID-19 cases dropped during the latest reporting week (July 1-7), returning to the downward trend that began in late May and then stopped for 1 week (June 24-30), when cases were up by 12.4%, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Children also represent a smaller share of cases, probably because of underreporting. “There has been a notable decline in the portion of reported weekly COVID-19 cases that are children,” the two groups said in their weekly COVID report. Although “cases are likely increasingly underreported for all age groups, this decline indicates that children are disproportionately undercounted in reported COVID-19 cases.”

Other measures, however, have been rising slowly but steadily since the spring. New admissions of patients aged 0-17 years with confirmed COVID, which were down to 0.13 per 100,000 population in early April, had climbed to 0.39 per 100,000 by July 7, the CDC said on its COVID Data Tracker.



Emergency department visits continue to show the same upward trend, despite a small decline in early June. A COVID diagnosis was involved in just 0.5% of ED visits in children aged 0-11 years on March 26, but by July 6 the rate was 4.7%. Increases were not as high among older children: From 0.3% on March 26 to 2.5% on July 6 for those aged 12-15 and from 0.3% to 2.4% for 16- and 17-year-olds, according to the CDC.

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The COVID-19 vaccination effort in the youngest children has begun much more slowly than the most recent rollout for older children, according to the Centers for Disease Control and Prevention.

Almost 263,000 children under age 5 years were vaccinated in the first 2 weeks after final approval on June 18, compared with the over 3 million children aged 5-11 years who received their first dose during the 2 weeks after approval in early November of 2021, based on CDC data last updated on July 7.

That approval, of course, came between the Delta and Omicron surges, when awareness was higher. The low initial uptake among those under age 5, however, was not unexpected by the Biden administration. “That number in and of itself is very much in line with our expectation, and we’re eager to continue working closely with partners to build on this start,” a senior administration official told ABC News.

With approval of the vaccine occurring after the school year was over, parents’ thoughts have been focused more on vacations and less on vaccinations. “Even before these vaccines officially became available, this was going to be a different rollout; it was going to take more time,” the official explained.
 

Incidence measures continue on different paths

New COVID-19 cases dropped during the latest reporting week (July 1-7), returning to the downward trend that began in late May and then stopped for 1 week (June 24-30), when cases were up by 12.4%, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Children also represent a smaller share of cases, probably because of underreporting. “There has been a notable decline in the portion of reported weekly COVID-19 cases that are children,” the two groups said in their weekly COVID report. Although “cases are likely increasingly underreported for all age groups, this decline indicates that children are disproportionately undercounted in reported COVID-19 cases.”

Other measures, however, have been rising slowly but steadily since the spring. New admissions of patients aged 0-17 years with confirmed COVID, which were down to 0.13 per 100,000 population in early April, had climbed to 0.39 per 100,000 by July 7, the CDC said on its COVID Data Tracker.



Emergency department visits continue to show the same upward trend, despite a small decline in early June. A COVID diagnosis was involved in just 0.5% of ED visits in children aged 0-11 years on March 26, but by July 6 the rate was 4.7%. Increases were not as high among older children: From 0.3% on March 26 to 2.5% on July 6 for those aged 12-15 and from 0.3% to 2.4% for 16- and 17-year-olds, according to the CDC.

The COVID-19 vaccination effort in the youngest children has begun much more slowly than the most recent rollout for older children, according to the Centers for Disease Control and Prevention.

Almost 263,000 children under age 5 years were vaccinated in the first 2 weeks after final approval on June 18, compared with the over 3 million children aged 5-11 years who received their first dose during the 2 weeks after approval in early November of 2021, based on CDC data last updated on July 7.

That approval, of course, came between the Delta and Omicron surges, when awareness was higher. The low initial uptake among those under age 5, however, was not unexpected by the Biden administration. “That number in and of itself is very much in line with our expectation, and we’re eager to continue working closely with partners to build on this start,” a senior administration official told ABC News.

With approval of the vaccine occurring after the school year was over, parents’ thoughts have been focused more on vacations and less on vaccinations. “Even before these vaccines officially became available, this was going to be a different rollout; it was going to take more time,” the official explained.
 

Incidence measures continue on different paths

New COVID-19 cases dropped during the latest reporting week (July 1-7), returning to the downward trend that began in late May and then stopped for 1 week (June 24-30), when cases were up by 12.4%, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Children also represent a smaller share of cases, probably because of underreporting. “There has been a notable decline in the portion of reported weekly COVID-19 cases that are children,” the two groups said in their weekly COVID report. Although “cases are likely increasingly underreported for all age groups, this decline indicates that children are disproportionately undercounted in reported COVID-19 cases.”

Other measures, however, have been rising slowly but steadily since the spring. New admissions of patients aged 0-17 years with confirmed COVID, which were down to 0.13 per 100,000 population in early April, had climbed to 0.39 per 100,000 by July 7, the CDC said on its COVID Data Tracker.



Emergency department visits continue to show the same upward trend, despite a small decline in early June. A COVID diagnosis was involved in just 0.5% of ED visits in children aged 0-11 years on March 26, but by July 6 the rate was 4.7%. Increases were not as high among older children: From 0.3% on March 26 to 2.5% on July 6 for those aged 12-15 and from 0.3% to 2.4% for 16- and 17-year-olds, according to the CDC.

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Childhood type 1 diabetes tests suggested at ages 2 and 6

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Wed, 08/10/2022 - 09:57

Screening children for type 1 diabetes–associated islet autoantibodies at ages 2 years and 6 years would identify most of those who go on to develop the condition by mid-adolescence, new data suggest.

Both genetic screening and islet-cell autoantibody screening for type 1 diabetes risk have become less expensive in recent years. Nonetheless, as of now, most children who receive such screening do so through programs that screen relatives of people who already have the condition, such as the global TrialNet program.

Some in the type 1 diabetes field have urged wider screening, with the rationale that knowledge of increased risk can prepare families to recognize the early signs of hyperglycemia and seek medical help to prevent the onset of diabetic ketoacidosis.

Moreover, potential therapies to prevent or delay type 1 diabetes are currently in development, including the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio).

However, given that the incidence of type 1 diabetes is about 1 in 300 children, any population-wide screening program would need to be implemented in the most efficient and cost-effective way possible with limited numbers of tests, say Mohamed Ghalwash, PhD, of the Center for Computational Health, IBM Research, Yorktown Heights, N.Y., and colleagues.

Results from their analysis of nearly 25,000 children from five prospective cohorts in Europe and the United States were published online  in Lancet Diabetes & Endocrinology.
 

Screening in kids feasible, but may need geographic tweaking

“Our results show that initial screening for islet autoantibodies at two ages (2 years and 6 years) is sensitive and efficient for public health translation but might require adjustment by country on the basis of population-specific disease characteristics,” Dr. Ghalwash and colleagues write.

In an accompanying editorial, pediatric endocrinologist Maria J. Redondo, MD, PhD, writes: “This study is timely because recent successes in preventing type 1 diabetes highlight the need to identify the best candidates for intervention ... This paper constitutes an important contribution to the literature.”

However, Dr. Redondo, of Baylor College of Medicine and Texas Children’s Hospital, Houston, also cautioned: “It remains to be seen whether Dr. Ghalwash and colleagues’ strategy could work in the general population, because all the participants in the combined dataset had genetic risk factors for the disease or a relative with type 1 diabetes, in whom performance is expected to be higher.”

She also noted that most participants were of northern European ancestry and that it is unknown whether the same or a similar screening strategy could be applied to individuals older than 15 years, in whom preclinical type 1 diabetes progresses more slowly.
 

Two-time childhood screening yielded high sensitivity, specificity

The data from a total of 24,662 participants were pooled from five prospective cohorts from Finland (DIPP), Germany (BABYDIAB), Sweden (DiPiS), and the United States (DAISY and DEW-IT).

All were at elevated risk for type 1 diabetes based on human leukocyte antigen (HLA) genotyping, and some had first-degree relatives with the condition. Participants were screened annually for three type 1 diabetes–associated autoantibodies up to age 15 years or the onset of type 1 diabetes.

During follow-up, 672 children developed type 1 diabetes by age 15 years and 6,050 did not. (The rest hadn’t yet reached age 15 years or type 1 diabetes onset.) The median age at first appearance of islet autoantibodies was 4.5 years.

A two-age screening strategy at 2 years and 6 years was more sensitive than screening at just one age, with a sensitivity of 82% and a positive predictive value of 79% for the development of type 1 diabetes by age 15 years.

The predictive value increased with the number of autoantibodies tested. For example, a single islet autoantibody at age 2 years indicated a 4-year risk of developing type 1 diabetes by age 5.99 years of 31%, while multiple antibody positivity at age 2 years carried a 4-year risk of 55%.

By age 6 years, the risk over the next 9 years was 39% if the test had been negative at age 2 years and 70% if the test had been positive at 2 years. But overall, a 6-year-old with multiple autoantibodies had an overall 83% risk of type 1 diabetes regardless of the test result at 2 years.

The predictive performance of sensitivity by age differed by country, suggesting that the optimal ages for autoantibody testing might differ by geographic region, Dr. Ghalwash and colleagues say.

Dr. Redondo commented, “The model might require adaptation to local factors that affect the progression and prevalence of type 1 diabetes.” And, she added, “important aspects, such as screening cost, global access, acceptability, and follow-up support will need to be addressed for this strategy to be a viable public health option.”

The study was funded by JDRF. Dr. Ghalwash and another author are employees of IBM. A third author was a JDRF employee when the research was done and is now an employee of Janssen Research and Development. Dr. Redondo has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Screening children for type 1 diabetes–associated islet autoantibodies at ages 2 years and 6 years would identify most of those who go on to develop the condition by mid-adolescence, new data suggest.

Both genetic screening and islet-cell autoantibody screening for type 1 diabetes risk have become less expensive in recent years. Nonetheless, as of now, most children who receive such screening do so through programs that screen relatives of people who already have the condition, such as the global TrialNet program.

Some in the type 1 diabetes field have urged wider screening, with the rationale that knowledge of increased risk can prepare families to recognize the early signs of hyperglycemia and seek medical help to prevent the onset of diabetic ketoacidosis.

Moreover, potential therapies to prevent or delay type 1 diabetes are currently in development, including the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio).

However, given that the incidence of type 1 diabetes is about 1 in 300 children, any population-wide screening program would need to be implemented in the most efficient and cost-effective way possible with limited numbers of tests, say Mohamed Ghalwash, PhD, of the Center for Computational Health, IBM Research, Yorktown Heights, N.Y., and colleagues.

Results from their analysis of nearly 25,000 children from five prospective cohorts in Europe and the United States were published online  in Lancet Diabetes & Endocrinology.
 

Screening in kids feasible, but may need geographic tweaking

“Our results show that initial screening for islet autoantibodies at two ages (2 years and 6 years) is sensitive and efficient for public health translation but might require adjustment by country on the basis of population-specific disease characteristics,” Dr. Ghalwash and colleagues write.

In an accompanying editorial, pediatric endocrinologist Maria J. Redondo, MD, PhD, writes: “This study is timely because recent successes in preventing type 1 diabetes highlight the need to identify the best candidates for intervention ... This paper constitutes an important contribution to the literature.”

However, Dr. Redondo, of Baylor College of Medicine and Texas Children’s Hospital, Houston, also cautioned: “It remains to be seen whether Dr. Ghalwash and colleagues’ strategy could work in the general population, because all the participants in the combined dataset had genetic risk factors for the disease or a relative with type 1 diabetes, in whom performance is expected to be higher.”

She also noted that most participants were of northern European ancestry and that it is unknown whether the same or a similar screening strategy could be applied to individuals older than 15 years, in whom preclinical type 1 diabetes progresses more slowly.
 

Two-time childhood screening yielded high sensitivity, specificity

The data from a total of 24,662 participants were pooled from five prospective cohorts from Finland (DIPP), Germany (BABYDIAB), Sweden (DiPiS), and the United States (DAISY and DEW-IT).

All were at elevated risk for type 1 diabetes based on human leukocyte antigen (HLA) genotyping, and some had first-degree relatives with the condition. Participants were screened annually for three type 1 diabetes–associated autoantibodies up to age 15 years or the onset of type 1 diabetes.

During follow-up, 672 children developed type 1 diabetes by age 15 years and 6,050 did not. (The rest hadn’t yet reached age 15 years or type 1 diabetes onset.) The median age at first appearance of islet autoantibodies was 4.5 years.

A two-age screening strategy at 2 years and 6 years was more sensitive than screening at just one age, with a sensitivity of 82% and a positive predictive value of 79% for the development of type 1 diabetes by age 15 years.

The predictive value increased with the number of autoantibodies tested. For example, a single islet autoantibody at age 2 years indicated a 4-year risk of developing type 1 diabetes by age 5.99 years of 31%, while multiple antibody positivity at age 2 years carried a 4-year risk of 55%.

By age 6 years, the risk over the next 9 years was 39% if the test had been negative at age 2 years and 70% if the test had been positive at 2 years. But overall, a 6-year-old with multiple autoantibodies had an overall 83% risk of type 1 diabetes regardless of the test result at 2 years.

The predictive performance of sensitivity by age differed by country, suggesting that the optimal ages for autoantibody testing might differ by geographic region, Dr. Ghalwash and colleagues say.

Dr. Redondo commented, “The model might require adaptation to local factors that affect the progression and prevalence of type 1 diabetes.” And, she added, “important aspects, such as screening cost, global access, acceptability, and follow-up support will need to be addressed for this strategy to be a viable public health option.”

The study was funded by JDRF. Dr. Ghalwash and another author are employees of IBM. A third author was a JDRF employee when the research was done and is now an employee of Janssen Research and Development. Dr. Redondo has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Screening children for type 1 diabetes–associated islet autoantibodies at ages 2 years and 6 years would identify most of those who go on to develop the condition by mid-adolescence, new data suggest.

Both genetic screening and islet-cell autoantibody screening for type 1 diabetes risk have become less expensive in recent years. Nonetheless, as of now, most children who receive such screening do so through programs that screen relatives of people who already have the condition, such as the global TrialNet program.

Some in the type 1 diabetes field have urged wider screening, with the rationale that knowledge of increased risk can prepare families to recognize the early signs of hyperglycemia and seek medical help to prevent the onset of diabetic ketoacidosis.

Moreover, potential therapies to prevent or delay type 1 diabetes are currently in development, including the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio).

However, given that the incidence of type 1 diabetes is about 1 in 300 children, any population-wide screening program would need to be implemented in the most efficient and cost-effective way possible with limited numbers of tests, say Mohamed Ghalwash, PhD, of the Center for Computational Health, IBM Research, Yorktown Heights, N.Y., and colleagues.

Results from their analysis of nearly 25,000 children from five prospective cohorts in Europe and the United States were published online  in Lancet Diabetes & Endocrinology.
 

Screening in kids feasible, but may need geographic tweaking

“Our results show that initial screening for islet autoantibodies at two ages (2 years and 6 years) is sensitive and efficient for public health translation but might require adjustment by country on the basis of population-specific disease characteristics,” Dr. Ghalwash and colleagues write.

In an accompanying editorial, pediatric endocrinologist Maria J. Redondo, MD, PhD, writes: “This study is timely because recent successes in preventing type 1 diabetes highlight the need to identify the best candidates for intervention ... This paper constitutes an important contribution to the literature.”

However, Dr. Redondo, of Baylor College of Medicine and Texas Children’s Hospital, Houston, also cautioned: “It remains to be seen whether Dr. Ghalwash and colleagues’ strategy could work in the general population, because all the participants in the combined dataset had genetic risk factors for the disease or a relative with type 1 diabetes, in whom performance is expected to be higher.”

She also noted that most participants were of northern European ancestry and that it is unknown whether the same or a similar screening strategy could be applied to individuals older than 15 years, in whom preclinical type 1 diabetes progresses more slowly.
 

Two-time childhood screening yielded high sensitivity, specificity

The data from a total of 24,662 participants were pooled from five prospective cohorts from Finland (DIPP), Germany (BABYDIAB), Sweden (DiPiS), and the United States (DAISY and DEW-IT).

All were at elevated risk for type 1 diabetes based on human leukocyte antigen (HLA) genotyping, and some had first-degree relatives with the condition. Participants were screened annually for three type 1 diabetes–associated autoantibodies up to age 15 years or the onset of type 1 diabetes.

During follow-up, 672 children developed type 1 diabetes by age 15 years and 6,050 did not. (The rest hadn’t yet reached age 15 years or type 1 diabetes onset.) The median age at first appearance of islet autoantibodies was 4.5 years.

A two-age screening strategy at 2 years and 6 years was more sensitive than screening at just one age, with a sensitivity of 82% and a positive predictive value of 79% for the development of type 1 diabetes by age 15 years.

The predictive value increased with the number of autoantibodies tested. For example, a single islet autoantibody at age 2 years indicated a 4-year risk of developing type 1 diabetes by age 5.99 years of 31%, while multiple antibody positivity at age 2 years carried a 4-year risk of 55%.

By age 6 years, the risk over the next 9 years was 39% if the test had been negative at age 2 years and 70% if the test had been positive at 2 years. But overall, a 6-year-old with multiple autoantibodies had an overall 83% risk of type 1 diabetes regardless of the test result at 2 years.

The predictive performance of sensitivity by age differed by country, suggesting that the optimal ages for autoantibody testing might differ by geographic region, Dr. Ghalwash and colleagues say.

Dr. Redondo commented, “The model might require adaptation to local factors that affect the progression and prevalence of type 1 diabetes.” And, she added, “important aspects, such as screening cost, global access, acceptability, and follow-up support will need to be addressed for this strategy to be a viable public health option.”

The study was funded by JDRF. Dr. Ghalwash and another author are employees of IBM. A third author was a JDRF employee when the research was done and is now an employee of Janssen Research and Development. Dr. Redondo has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Social media in the lives of adolescents

Article Type
Changed
Tue, 07/12/2022 - 14:05

Adolescence is a time of growing autonomy fueled by puberty, intellectual development, and identity formation. Social media engages adolescents by giving them easy access to (semi) private communication with peers, the ability to safely explore their sexuality, and easily investigate issues of intellectual curiosity, as they move from childhood to older adolescence. Social media facilitates the creation of a teenager’s own world, separate and distinct from adult concern or scrutiny. It is clearly compelling for adolescents, but we are in the early days of understanding the effect of various types of digital activities on the health and well-being of youth. There is evidence that for some, the addictive potential of these applications is potent, exacerbating or triggering mood, anxiety, and eating disorder symptoms. Their drive to explore their identity and relationships and their immature capacity to regulate emotions and behaviors make the risks of overuse substantial. But it would be impossible (and probably socially very costly) to simply avoid social media. So how to discuss its healthy use with your patients and their parents?

The data

Social media are digital communication platforms that allow users to build a public profile and then accumulate a network of followers, and follow other users, based on shared interests. They include FaceBook, Instagram, Snapchat, YouTube, and Twitter. Surveys demonstrated that 90% of U.S. adolescents use social media, with 75% having at least one social media profile and over half visiting social media sites at least once daily. Adolescents spend over 7 hours daily on their phones, not including time devoted to online schoolwork, and 8- to 12-year-olds are not far behind at almost 5 hours of daily phone use. On average, 39% of adolescent screen time is spent on passive consumption, 26% on social media, 25% on interactive activities (browsing the web, interactive video gaming) and 3% on content creation (coding, etc). There was considerable variability in survey results, and differences between genders, with boys engaged in video games almost eight times as often as girls, and girls in social media nearly twice as often as boys.1

The research

There is a growing body of research devoted to understanding the effects of all of this digital activity on youth health and well-being.

Dr. Susan D. Swick

A large, longitudinal study of Canadian 13- to 17-year-olds found that time spent on social media or watching television was strongly associated with depressive and anxiety symptoms, with a robust dose-response relationship.2 However, causality is not clear, as anxious, shy, and depressed adolescents may use more social media as a consequence of their mood. Interestingly, there was no such relationship with mood and anxiety symptoms and time spent on video games.3 For youth with depression and anxiety, time spent on social media has been strongly associated with increased levels of self-reported distress, self-injury and suicidality, but again, causality is hard to prove.

 

 

One very large study from the United Kingdom (including more than 10,000 participants), demonstrated a strong relationship between time spent on social media and severity of depressive symptoms, with a more pronounced effect in girls than in boys.4 Many more nuanced studies have demonstrated that excessive time spent on social media, the presence of an addictive pattern of use, and the degree to which an adolescent’s sense of well-being is connected to social media are the variables that strongly predict an association with worsening depressive or anxiety symptoms.5

Several studies have demonstrated that low to moderate use of social media, and use to gather information and make plans were associated with better scores of emotional self-regulation and lower rates of depressive symptoms in teens.6 It seems safe to say that social media can be useful and fun, but that too much can be bad for you. So help your adolescent patients to expand their perspective on its use by discussing it with them.
 

Make them curious about quantity

Most teens feel they do not have enough time for all of the things they need to do, so invite them to play detective by using their phone’s applications that can track their time spent online and in different apps.

Dr. Michael S. Jellinek

Remind them that these apps were designed to be so engaging that for some addiction is a real problem. As with tobacco, addiction is the business model by which these companies earn advertising dollars. Indeed, adolescents are the target demographic, as they are most sensitive to social rewards and are the most valuable audience for advertisers. Engage their natural suspicion of authority by pointing out that with every hour on Insta, someone else is making a lot of money. They get to choose how they want to relax, connect with friends, and explore the world, so help them to be aware of how these apps are designed to keep them from choosing.

Raise awareness of vulnerability

Adolescents who have attention-deficit/hyperactivity disorder already have difficulty with impulse control and with shifting their attention to less engaging activities. Adolescents with anxiety are prone to avoid stressful situations, but still hunger for knowledge and connections. Adolescents with depression are managing low motivation and self-esteem, and the rewards of social media may keep them from exercise and actual social engagement that are critical to their treatment. Youth with eating disorders are especially prone to critical comparison of themselves to others, feeding their distorted body images. Help your patients with these common illnesses to be aware of how social media may make their treatment harder, rather than being the source of relief it may feel like.

Protect their health

For all young people, too much time spent in virtual activities and passive media consumption may not leave enough time to explore potential interests, talents, or relationships. These are important activities throughout life, but they are the central developmental tasks of adolescence. They also need 8-10 hours of sleep nightly and regular exercise. And of course, they have homework! Help them to think about how to use their time wisely to support satisfying relationships and activities, with time for relaxation and good health.

Keep parents in the room for these discussions

State that most of us have difficulty putting down our phones. Children and teens need adults who model striving for balance in all areas of choice. Just as we try to teach them to make good choices about food, getting excellent nutrition while still valuing taste and pleasure, we can talk about how to balance virtual activities with actual activities, work with play, and effort with relaxation. You can help expand your young patients’ self-awareness, acknowledge the fun and utility of their digital time, and enhance their sense of how we must all learn how to put screens down sometimes. In so doing, you can help families to ensure that they are engaging with the digital tools and toys available to all of us in ways that can support their health and well-being.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
 

References

1. Geena Davis Institute on Gender and Media. The Common Sense Census: Media Use by Teens and Tweens, 2015.

2. Abi-Jaoude E et al. CMAJ 2020;192(6):E136-41.

3. Boers E et al. Can J Psychiatry. 2020 Mar;65(3):206-8.

4. Kelly Y et al. EClinicalMedicine. 2019 Jan 4;6:59-68.

5. Vidal C et al. Int Rev Psychiatry. 2020 May;32(3):235-53.

6. Coyne SM et al. J Res Adolescence. 2019;29(4):897-907.

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Adolescence is a time of growing autonomy fueled by puberty, intellectual development, and identity formation. Social media engages adolescents by giving them easy access to (semi) private communication with peers, the ability to safely explore their sexuality, and easily investigate issues of intellectual curiosity, as they move from childhood to older adolescence. Social media facilitates the creation of a teenager’s own world, separate and distinct from adult concern or scrutiny. It is clearly compelling for adolescents, but we are in the early days of understanding the effect of various types of digital activities on the health and well-being of youth. There is evidence that for some, the addictive potential of these applications is potent, exacerbating or triggering mood, anxiety, and eating disorder symptoms. Their drive to explore their identity and relationships and their immature capacity to regulate emotions and behaviors make the risks of overuse substantial. But it would be impossible (and probably socially very costly) to simply avoid social media. So how to discuss its healthy use with your patients and their parents?

The data

Social media are digital communication platforms that allow users to build a public profile and then accumulate a network of followers, and follow other users, based on shared interests. They include FaceBook, Instagram, Snapchat, YouTube, and Twitter. Surveys demonstrated that 90% of U.S. adolescents use social media, with 75% having at least one social media profile and over half visiting social media sites at least once daily. Adolescents spend over 7 hours daily on their phones, not including time devoted to online schoolwork, and 8- to 12-year-olds are not far behind at almost 5 hours of daily phone use. On average, 39% of adolescent screen time is spent on passive consumption, 26% on social media, 25% on interactive activities (browsing the web, interactive video gaming) and 3% on content creation (coding, etc). There was considerable variability in survey results, and differences between genders, with boys engaged in video games almost eight times as often as girls, and girls in social media nearly twice as often as boys.1

The research

There is a growing body of research devoted to understanding the effects of all of this digital activity on youth health and well-being.

Dr. Susan D. Swick

A large, longitudinal study of Canadian 13- to 17-year-olds found that time spent on social media or watching television was strongly associated with depressive and anxiety symptoms, with a robust dose-response relationship.2 However, causality is not clear, as anxious, shy, and depressed adolescents may use more social media as a consequence of their mood. Interestingly, there was no such relationship with mood and anxiety symptoms and time spent on video games.3 For youth with depression and anxiety, time spent on social media has been strongly associated with increased levels of self-reported distress, self-injury and suicidality, but again, causality is hard to prove.

 

 

One very large study from the United Kingdom (including more than 10,000 participants), demonstrated a strong relationship between time spent on social media and severity of depressive symptoms, with a more pronounced effect in girls than in boys.4 Many more nuanced studies have demonstrated that excessive time spent on social media, the presence of an addictive pattern of use, and the degree to which an adolescent’s sense of well-being is connected to social media are the variables that strongly predict an association with worsening depressive or anxiety symptoms.5

Several studies have demonstrated that low to moderate use of social media, and use to gather information and make plans were associated with better scores of emotional self-regulation and lower rates of depressive symptoms in teens.6 It seems safe to say that social media can be useful and fun, but that too much can be bad for you. So help your adolescent patients to expand their perspective on its use by discussing it with them.
 

Make them curious about quantity

Most teens feel they do not have enough time for all of the things they need to do, so invite them to play detective by using their phone’s applications that can track their time spent online and in different apps.

Dr. Michael S. Jellinek

Remind them that these apps were designed to be so engaging that for some addiction is a real problem. As with tobacco, addiction is the business model by which these companies earn advertising dollars. Indeed, adolescents are the target demographic, as they are most sensitive to social rewards and are the most valuable audience for advertisers. Engage their natural suspicion of authority by pointing out that with every hour on Insta, someone else is making a lot of money. They get to choose how they want to relax, connect with friends, and explore the world, so help them to be aware of how these apps are designed to keep them from choosing.

Raise awareness of vulnerability

Adolescents who have attention-deficit/hyperactivity disorder already have difficulty with impulse control and with shifting their attention to less engaging activities. Adolescents with anxiety are prone to avoid stressful situations, but still hunger for knowledge and connections. Adolescents with depression are managing low motivation and self-esteem, and the rewards of social media may keep them from exercise and actual social engagement that are critical to their treatment. Youth with eating disorders are especially prone to critical comparison of themselves to others, feeding their distorted body images. Help your patients with these common illnesses to be aware of how social media may make their treatment harder, rather than being the source of relief it may feel like.

Protect their health

For all young people, too much time spent in virtual activities and passive media consumption may not leave enough time to explore potential interests, talents, or relationships. These are important activities throughout life, but they are the central developmental tasks of adolescence. They also need 8-10 hours of sleep nightly and regular exercise. And of course, they have homework! Help them to think about how to use their time wisely to support satisfying relationships and activities, with time for relaxation and good health.

Keep parents in the room for these discussions

State that most of us have difficulty putting down our phones. Children and teens need adults who model striving for balance in all areas of choice. Just as we try to teach them to make good choices about food, getting excellent nutrition while still valuing taste and pleasure, we can talk about how to balance virtual activities with actual activities, work with play, and effort with relaxation. You can help expand your young patients’ self-awareness, acknowledge the fun and utility of their digital time, and enhance their sense of how we must all learn how to put screens down sometimes. In so doing, you can help families to ensure that they are engaging with the digital tools and toys available to all of us in ways that can support their health and well-being.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
 

References

1. Geena Davis Institute on Gender and Media. The Common Sense Census: Media Use by Teens and Tweens, 2015.

2. Abi-Jaoude E et al. CMAJ 2020;192(6):E136-41.

3. Boers E et al. Can J Psychiatry. 2020 Mar;65(3):206-8.

4. Kelly Y et al. EClinicalMedicine. 2019 Jan 4;6:59-68.

5. Vidal C et al. Int Rev Psychiatry. 2020 May;32(3):235-53.

6. Coyne SM et al. J Res Adolescence. 2019;29(4):897-907.

Adolescence is a time of growing autonomy fueled by puberty, intellectual development, and identity formation. Social media engages adolescents by giving them easy access to (semi) private communication with peers, the ability to safely explore their sexuality, and easily investigate issues of intellectual curiosity, as they move from childhood to older adolescence. Social media facilitates the creation of a teenager’s own world, separate and distinct from adult concern or scrutiny. It is clearly compelling for adolescents, but we are in the early days of understanding the effect of various types of digital activities on the health and well-being of youth. There is evidence that for some, the addictive potential of these applications is potent, exacerbating or triggering mood, anxiety, and eating disorder symptoms. Their drive to explore their identity and relationships and their immature capacity to regulate emotions and behaviors make the risks of overuse substantial. But it would be impossible (and probably socially very costly) to simply avoid social media. So how to discuss its healthy use with your patients and their parents?

The data

Social media are digital communication platforms that allow users to build a public profile and then accumulate a network of followers, and follow other users, based on shared interests. They include FaceBook, Instagram, Snapchat, YouTube, and Twitter. Surveys demonstrated that 90% of U.S. adolescents use social media, with 75% having at least one social media profile and over half visiting social media sites at least once daily. Adolescents spend over 7 hours daily on their phones, not including time devoted to online schoolwork, and 8- to 12-year-olds are not far behind at almost 5 hours of daily phone use. On average, 39% of adolescent screen time is spent on passive consumption, 26% on social media, 25% on interactive activities (browsing the web, interactive video gaming) and 3% on content creation (coding, etc). There was considerable variability in survey results, and differences between genders, with boys engaged in video games almost eight times as often as girls, and girls in social media nearly twice as often as boys.1

The research

There is a growing body of research devoted to understanding the effects of all of this digital activity on youth health and well-being.

Dr. Susan D. Swick

A large, longitudinal study of Canadian 13- to 17-year-olds found that time spent on social media or watching television was strongly associated with depressive and anxiety symptoms, with a robust dose-response relationship.2 However, causality is not clear, as anxious, shy, and depressed adolescents may use more social media as a consequence of their mood. Interestingly, there was no such relationship with mood and anxiety symptoms and time spent on video games.3 For youth with depression and anxiety, time spent on social media has been strongly associated with increased levels of self-reported distress, self-injury and suicidality, but again, causality is hard to prove.

 

 

One very large study from the United Kingdom (including more than 10,000 participants), demonstrated a strong relationship between time spent on social media and severity of depressive symptoms, with a more pronounced effect in girls than in boys.4 Many more nuanced studies have demonstrated that excessive time spent on social media, the presence of an addictive pattern of use, and the degree to which an adolescent’s sense of well-being is connected to social media are the variables that strongly predict an association with worsening depressive or anxiety symptoms.5

Several studies have demonstrated that low to moderate use of social media, and use to gather information and make plans were associated with better scores of emotional self-regulation and lower rates of depressive symptoms in teens.6 It seems safe to say that social media can be useful and fun, but that too much can be bad for you. So help your adolescent patients to expand their perspective on its use by discussing it with them.
 

Make them curious about quantity

Most teens feel they do not have enough time for all of the things they need to do, so invite them to play detective by using their phone’s applications that can track their time spent online and in different apps.

Dr. Michael S. Jellinek

Remind them that these apps were designed to be so engaging that for some addiction is a real problem. As with tobacco, addiction is the business model by which these companies earn advertising dollars. Indeed, adolescents are the target demographic, as they are most sensitive to social rewards and are the most valuable audience for advertisers. Engage their natural suspicion of authority by pointing out that with every hour on Insta, someone else is making a lot of money. They get to choose how they want to relax, connect with friends, and explore the world, so help them to be aware of how these apps are designed to keep them from choosing.

Raise awareness of vulnerability

Adolescents who have attention-deficit/hyperactivity disorder already have difficulty with impulse control and with shifting their attention to less engaging activities. Adolescents with anxiety are prone to avoid stressful situations, but still hunger for knowledge and connections. Adolescents with depression are managing low motivation and self-esteem, and the rewards of social media may keep them from exercise and actual social engagement that are critical to their treatment. Youth with eating disorders are especially prone to critical comparison of themselves to others, feeding their distorted body images. Help your patients with these common illnesses to be aware of how social media may make their treatment harder, rather than being the source of relief it may feel like.

Protect their health

For all young people, too much time spent in virtual activities and passive media consumption may not leave enough time to explore potential interests, talents, or relationships. These are important activities throughout life, but they are the central developmental tasks of adolescence. They also need 8-10 hours of sleep nightly and regular exercise. And of course, they have homework! Help them to think about how to use their time wisely to support satisfying relationships and activities, with time for relaxation and good health.

Keep parents in the room for these discussions

State that most of us have difficulty putting down our phones. Children and teens need adults who model striving for balance in all areas of choice. Just as we try to teach them to make good choices about food, getting excellent nutrition while still valuing taste and pleasure, we can talk about how to balance virtual activities with actual activities, work with play, and effort with relaxation. You can help expand your young patients’ self-awareness, acknowledge the fun and utility of their digital time, and enhance their sense of how we must all learn how to put screens down sometimes. In so doing, you can help families to ensure that they are engaging with the digital tools and toys available to all of us in ways that can support their health and well-being.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
 

References

1. Geena Davis Institute on Gender and Media. The Common Sense Census: Media Use by Teens and Tweens, 2015.

2. Abi-Jaoude E et al. CMAJ 2020;192(6):E136-41.

3. Boers E et al. Can J Psychiatry. 2020 Mar;65(3):206-8.

4. Kelly Y et al. EClinicalMedicine. 2019 Jan 4;6:59-68.

5. Vidal C et al. Int Rev Psychiatry. 2020 May;32(3):235-53.

6. Coyne SM et al. J Res Adolescence. 2019;29(4):897-907.

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Do behavioral interventions improve nighttime sleep in children < 1 year old?

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Do behavioral interventions improve nighttime sleep in children < 1 year old?

Most interventions resulted in at least modest improvements in sleep

A randomized controlled trial (RCT) of 279 newborn infants and their mothers evaluated developmentally appropriate sleep interventions.1 Mothers were given guidance on bedtime sleep routines, including starting the routine 30 to 45 minutes before bedtime, choosing age-appropriate calming bedtime activities, not using feeding as the last step before bedtime, and offering the child choices with their routine. Mothers were also given guidance on sleep location and behaviors, including recommendations on the best bedtime (between 7 and 8 pm), avoidance of a stimulating environment, and transition of the infant to their own room by age 3 months. To address nighttime awakenings, the researchers advised not waking the infant routinely to feed, allowing the infant some time to self-soothe after waking at night, and keeping nighttime interactions with the child boring.

These interventions were compared to a control group that received instructions on crib safety, sudden infant death syndrome prevention, and other sleep safety recommendations. Infant nocturnal sleep duration was determined by maternal report using the Brief Infant Sleep Questionnaire (BISQ). After 40 weeks, infants in the intervention group demonstrated longer sleep duration than did those in the control group (624.6 ± 67.6 minutes vs 602.9 ± 76.1 minutes; P = .01).1

An RCT of 82 infants (ages 2-4 months) and their mothers evaluated the effect of behavioral sleep interventions on maternal and infant sleep.2 Parents were offered either a 90-minute class and take-home booklet about behavioral sleep interventions or a 30-minute training on general infant safety with an accompanying pamphlet.

The behavioral interventions booklet included instructions on differentiating day and night routines for baby, avoiding digital devices and television in the evenings, playing more active games in the morning, dimming lights and reducing house noises in the afternoon, and having a consistent nighttime routine with consistent bedtime and sleep space. Participants completed an infant sleep diary prior to the intervention and repeated the sleep diary 8 weeks after the intervention. The infants whose mothers received the education on behavioral sleep interventions demonstrated an increase in nighttime sleep duration when compared to the control group (7.4 to 8.8 hours vs 7.3 to 7.5 hours; ANCOVA P < .001).

An RCT of 235 families with infants ages 6 to 8 months evaluated the effect of 45 minutes of nurse-provided education regarding normal infant sleep, effects of inadequate sleep, setting limits around infant sleep, importance of daytime routines, and negative sleep associations combined with a booklet and weekly phone follow-ups.3 This intervention was compared to routine infant education. At age 6 weeks, infants were monitored for 48 hours with actigraphy and the mothers completed a sleep diary to correlate activities. There was no difference in average nightly waking (2 nightly wakes; risk difference = –0.2%; 95% CI, –1.32 to 0.91).

The low cost and risk of these behavioral interventions to improve infants’ sleep make them worthwhile.

An RCT of 268 families with infants (ages 2-3 weeks) evaluated the effect of 45 minutes of nurse-provided education on behavioral sleep interventions including the cyclical nature of infant sleep, environmental factors that influence sleep, and parent-independent sleep cues (eg, leaving a settling infant alone for 5 minutes before responding) combined with written information.4 This was compared to infants receiving standard care without parental sleep intervention education. Participants recorded sleep diaries for 7 days when their infant reached age 6 weeks and again at age 12 weeks. At both 6 weeks and 12 weeks, there was a significant increase in infant nocturnal sleep time in the intervention group vs the control group (mean difference [MD] at 6 weeks = 0.5 hours; 95% CI, 0.32 to 0.69 vs MD at 12 weeks = 0.64 hours; 95% CI, 0.19 to 0.89).

A nonrandomized controlled trial with 84 mothers and infants (ages 0-6 months) evaluated the effectiveness of a multifaceted intervention involving brief focused negotiation by pediatricians, motivational counseling by a health educator, and group parenting workshops, compared to mother–infant pairs receiving standard care.5 Parents completed the BISQ at 0 and 6 months to assess nocturnal sleep duration. At 6 months, the intervention group had a significantly higher increase in infant nocturnal sleep duration compared to the control group (mean increase = 1.9 vs 1.3 hours; P = .05).

In a prospective cohort study involving 79 infants (ages 3-24 months) with parent- or pediatrician-reported day and night sleep problems, parents were given education on the promotion of nighttime sleep by gradually reducing contact with the infant over several nights and only leaving the room after the infant fell asleep or allowing the child to self-soothe for 1-3 minutes.6 The intervention was performed over 3 weeks, with in-person follow-up performed on Day 15 and phone follow-up on Days 8 and 21. Infants in this study demonstrated an increase in the average hours of total night sleep from 10.2 to 10.5 hours (P < .001).

Editor’s takeaway

Providing behavioral recommendations to parents about infant sleep routines improves sleep duration. This increased sleep duration, and the supporting evidence, is modest, but the low cost and risk of these interventions make them worthwhile.

References

1. Paul IM, Savage JS, Anzman-Frasca S, et al. INSIGHT responsive parenting intervention and infant sleep. Pediatrics. 2016;138:e20160762. doi:10.1542/peds.2016-0762

2. Rouzafzoon M, Farnam F, Khakbazan Z. The effects of infant behavioural sleep interventions on maternal sleep and mood, and infant sleep: a randomised controlled trial. J Sleep Res. 2021;30:e13344. doi: 10.1111/jsr.13344

3. Hall WA, Hutton E, Brant RF, et al. A randomized controlled trial of an intervention for infants’ behavioral sleep problems. BMC Pediatr. 2015;15:181. doi:10.1186/s12887-015-0492-7

4. Symon BG, Marley JE, Martin AJ, et al. Effect of a consultation teaching behaviour modification on sleep performance in infants: a randomised controlled trial. Med J Aust. 2005;182:215-218. doi: 10.5694/j.1326-5377.2005.tb06669.x

5. Taveras EM, Blackburn K, Gillman MW, et al. First steps for mommy and me: a pilot intervention to improve nutrition and physical activity behaviors of postpartum mothers and their infants. Matern Child Health J. 2011;15:1217-1227. doi: 10.1007/s10995-010-0696-2

6. Skuladottir A, Thome M, Ramel A. Improving day and night sleep problems in infants by changing day time sleep rhythm: a single group before and after study. Int J Nurs Stud. 2005;42:843-850. doi: 10.1016/j.ijnurstu.2004.12.004

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BreAnna Houss, MD
Madhav Narayan, MD
Corey Lyon, DO

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Kristen DeSanto, MSLS, MS, RD
University of Colorado Health Sciences Library, Denver

DEPUTY EDITOR
Rick Guthmann, MD, MPH

Advocate Health Care Illinois Masonic Medical Center Program, Chicago

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Corey Lyon, DO

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University of Colorado Health Sciences Library, Denver

DEPUTY EDITOR
Rick Guthmann, MD, MPH

Advocate Health Care Illinois Masonic Medical Center Program, Chicago

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BreAnna Houss, MD
Madhav Narayan, MD
Corey Lyon, DO

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University of Colorado Health Sciences Library, Denver

DEPUTY EDITOR
Rick Guthmann, MD, MPH

Advocate Health Care Illinois Masonic Medical Center Program, Chicago

Article PDF
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Most interventions resulted in at least modest improvements in sleep

A randomized controlled trial (RCT) of 279 newborn infants and their mothers evaluated developmentally appropriate sleep interventions.1 Mothers were given guidance on bedtime sleep routines, including starting the routine 30 to 45 minutes before bedtime, choosing age-appropriate calming bedtime activities, not using feeding as the last step before bedtime, and offering the child choices with their routine. Mothers were also given guidance on sleep location and behaviors, including recommendations on the best bedtime (between 7 and 8 pm), avoidance of a stimulating environment, and transition of the infant to their own room by age 3 months. To address nighttime awakenings, the researchers advised not waking the infant routinely to feed, allowing the infant some time to self-soothe after waking at night, and keeping nighttime interactions with the child boring.

These interventions were compared to a control group that received instructions on crib safety, sudden infant death syndrome prevention, and other sleep safety recommendations. Infant nocturnal sleep duration was determined by maternal report using the Brief Infant Sleep Questionnaire (BISQ). After 40 weeks, infants in the intervention group demonstrated longer sleep duration than did those in the control group (624.6 ± 67.6 minutes vs 602.9 ± 76.1 minutes; P = .01).1

An RCT of 82 infants (ages 2-4 months) and their mothers evaluated the effect of behavioral sleep interventions on maternal and infant sleep.2 Parents were offered either a 90-minute class and take-home booklet about behavioral sleep interventions or a 30-minute training on general infant safety with an accompanying pamphlet.

The behavioral interventions booklet included instructions on differentiating day and night routines for baby, avoiding digital devices and television in the evenings, playing more active games in the morning, dimming lights and reducing house noises in the afternoon, and having a consistent nighttime routine with consistent bedtime and sleep space. Participants completed an infant sleep diary prior to the intervention and repeated the sleep diary 8 weeks after the intervention. The infants whose mothers received the education on behavioral sleep interventions demonstrated an increase in nighttime sleep duration when compared to the control group (7.4 to 8.8 hours vs 7.3 to 7.5 hours; ANCOVA P < .001).

An RCT of 235 families with infants ages 6 to 8 months evaluated the effect of 45 minutes of nurse-provided education regarding normal infant sleep, effects of inadequate sleep, setting limits around infant sleep, importance of daytime routines, and negative sleep associations combined with a booklet and weekly phone follow-ups.3 This intervention was compared to routine infant education. At age 6 weeks, infants were monitored for 48 hours with actigraphy and the mothers completed a sleep diary to correlate activities. There was no difference in average nightly waking (2 nightly wakes; risk difference = –0.2%; 95% CI, –1.32 to 0.91).

The low cost and risk of these behavioral interventions to improve infants’ sleep make them worthwhile.

An RCT of 268 families with infants (ages 2-3 weeks) evaluated the effect of 45 minutes of nurse-provided education on behavioral sleep interventions including the cyclical nature of infant sleep, environmental factors that influence sleep, and parent-independent sleep cues (eg, leaving a settling infant alone for 5 minutes before responding) combined with written information.4 This was compared to infants receiving standard care without parental sleep intervention education. Participants recorded sleep diaries for 7 days when their infant reached age 6 weeks and again at age 12 weeks. At both 6 weeks and 12 weeks, there was a significant increase in infant nocturnal sleep time in the intervention group vs the control group (mean difference [MD] at 6 weeks = 0.5 hours; 95% CI, 0.32 to 0.69 vs MD at 12 weeks = 0.64 hours; 95% CI, 0.19 to 0.89).

A nonrandomized controlled trial with 84 mothers and infants (ages 0-6 months) evaluated the effectiveness of a multifaceted intervention involving brief focused negotiation by pediatricians, motivational counseling by a health educator, and group parenting workshops, compared to mother–infant pairs receiving standard care.5 Parents completed the BISQ at 0 and 6 months to assess nocturnal sleep duration. At 6 months, the intervention group had a significantly higher increase in infant nocturnal sleep duration compared to the control group (mean increase = 1.9 vs 1.3 hours; P = .05).

In a prospective cohort study involving 79 infants (ages 3-24 months) with parent- or pediatrician-reported day and night sleep problems, parents were given education on the promotion of nighttime sleep by gradually reducing contact with the infant over several nights and only leaving the room after the infant fell asleep or allowing the child to self-soothe for 1-3 minutes.6 The intervention was performed over 3 weeks, with in-person follow-up performed on Day 15 and phone follow-up on Days 8 and 21. Infants in this study demonstrated an increase in the average hours of total night sleep from 10.2 to 10.5 hours (P < .001).

Editor’s takeaway

Providing behavioral recommendations to parents about infant sleep routines improves sleep duration. This increased sleep duration, and the supporting evidence, is modest, but the low cost and risk of these interventions make them worthwhile.

Most interventions resulted in at least modest improvements in sleep

A randomized controlled trial (RCT) of 279 newborn infants and their mothers evaluated developmentally appropriate sleep interventions.1 Mothers were given guidance on bedtime sleep routines, including starting the routine 30 to 45 minutes before bedtime, choosing age-appropriate calming bedtime activities, not using feeding as the last step before bedtime, and offering the child choices with their routine. Mothers were also given guidance on sleep location and behaviors, including recommendations on the best bedtime (between 7 and 8 pm), avoidance of a stimulating environment, and transition of the infant to their own room by age 3 months. To address nighttime awakenings, the researchers advised not waking the infant routinely to feed, allowing the infant some time to self-soothe after waking at night, and keeping nighttime interactions with the child boring.

These interventions were compared to a control group that received instructions on crib safety, sudden infant death syndrome prevention, and other sleep safety recommendations. Infant nocturnal sleep duration was determined by maternal report using the Brief Infant Sleep Questionnaire (BISQ). After 40 weeks, infants in the intervention group demonstrated longer sleep duration than did those in the control group (624.6 ± 67.6 minutes vs 602.9 ± 76.1 minutes; P = .01).1

An RCT of 82 infants (ages 2-4 months) and their mothers evaluated the effect of behavioral sleep interventions on maternal and infant sleep.2 Parents were offered either a 90-minute class and take-home booklet about behavioral sleep interventions or a 30-minute training on general infant safety with an accompanying pamphlet.

The behavioral interventions booklet included instructions on differentiating day and night routines for baby, avoiding digital devices and television in the evenings, playing more active games in the morning, dimming lights and reducing house noises in the afternoon, and having a consistent nighttime routine with consistent bedtime and sleep space. Participants completed an infant sleep diary prior to the intervention and repeated the sleep diary 8 weeks after the intervention. The infants whose mothers received the education on behavioral sleep interventions demonstrated an increase in nighttime sleep duration when compared to the control group (7.4 to 8.8 hours vs 7.3 to 7.5 hours; ANCOVA P < .001).

An RCT of 235 families with infants ages 6 to 8 months evaluated the effect of 45 minutes of nurse-provided education regarding normal infant sleep, effects of inadequate sleep, setting limits around infant sleep, importance of daytime routines, and negative sleep associations combined with a booklet and weekly phone follow-ups.3 This intervention was compared to routine infant education. At age 6 weeks, infants were monitored for 48 hours with actigraphy and the mothers completed a sleep diary to correlate activities. There was no difference in average nightly waking (2 nightly wakes; risk difference = –0.2%; 95% CI, –1.32 to 0.91).

The low cost and risk of these behavioral interventions to improve infants’ sleep make them worthwhile.

An RCT of 268 families with infants (ages 2-3 weeks) evaluated the effect of 45 minutes of nurse-provided education on behavioral sleep interventions including the cyclical nature of infant sleep, environmental factors that influence sleep, and parent-independent sleep cues (eg, leaving a settling infant alone for 5 minutes before responding) combined with written information.4 This was compared to infants receiving standard care without parental sleep intervention education. Participants recorded sleep diaries for 7 days when their infant reached age 6 weeks and again at age 12 weeks. At both 6 weeks and 12 weeks, there was a significant increase in infant nocturnal sleep time in the intervention group vs the control group (mean difference [MD] at 6 weeks = 0.5 hours; 95% CI, 0.32 to 0.69 vs MD at 12 weeks = 0.64 hours; 95% CI, 0.19 to 0.89).

A nonrandomized controlled trial with 84 mothers and infants (ages 0-6 months) evaluated the effectiveness of a multifaceted intervention involving brief focused negotiation by pediatricians, motivational counseling by a health educator, and group parenting workshops, compared to mother–infant pairs receiving standard care.5 Parents completed the BISQ at 0 and 6 months to assess nocturnal sleep duration. At 6 months, the intervention group had a significantly higher increase in infant nocturnal sleep duration compared to the control group (mean increase = 1.9 vs 1.3 hours; P = .05).

In a prospective cohort study involving 79 infants (ages 3-24 months) with parent- or pediatrician-reported day and night sleep problems, parents were given education on the promotion of nighttime sleep by gradually reducing contact with the infant over several nights and only leaving the room after the infant fell asleep or allowing the child to self-soothe for 1-3 minutes.6 The intervention was performed over 3 weeks, with in-person follow-up performed on Day 15 and phone follow-up on Days 8 and 21. Infants in this study demonstrated an increase in the average hours of total night sleep from 10.2 to 10.5 hours (P < .001).

Editor’s takeaway

Providing behavioral recommendations to parents about infant sleep routines improves sleep duration. This increased sleep duration, and the supporting evidence, is modest, but the low cost and risk of these interventions make them worthwhile.

References

1. Paul IM, Savage JS, Anzman-Frasca S, et al. INSIGHT responsive parenting intervention and infant sleep. Pediatrics. 2016;138:e20160762. doi:10.1542/peds.2016-0762

2. Rouzafzoon M, Farnam F, Khakbazan Z. The effects of infant behavioural sleep interventions on maternal sleep and mood, and infant sleep: a randomised controlled trial. J Sleep Res. 2021;30:e13344. doi: 10.1111/jsr.13344

3. Hall WA, Hutton E, Brant RF, et al. A randomized controlled trial of an intervention for infants’ behavioral sleep problems. BMC Pediatr. 2015;15:181. doi:10.1186/s12887-015-0492-7

4. Symon BG, Marley JE, Martin AJ, et al. Effect of a consultation teaching behaviour modification on sleep performance in infants: a randomised controlled trial. Med J Aust. 2005;182:215-218. doi: 10.5694/j.1326-5377.2005.tb06669.x

5. Taveras EM, Blackburn K, Gillman MW, et al. First steps for mommy and me: a pilot intervention to improve nutrition and physical activity behaviors of postpartum mothers and their infants. Matern Child Health J. 2011;15:1217-1227. doi: 10.1007/s10995-010-0696-2

6. Skuladottir A, Thome M, Ramel A. Improving day and night sleep problems in infants by changing day time sleep rhythm: a single group before and after study. Int J Nurs Stud. 2005;42:843-850. doi: 10.1016/j.ijnurstu.2004.12.004

References

1. Paul IM, Savage JS, Anzman-Frasca S, et al. INSIGHT responsive parenting intervention and infant sleep. Pediatrics. 2016;138:e20160762. doi:10.1542/peds.2016-0762

2. Rouzafzoon M, Farnam F, Khakbazan Z. The effects of infant behavioural sleep interventions on maternal sleep and mood, and infant sleep: a randomised controlled trial. J Sleep Res. 2021;30:e13344. doi: 10.1111/jsr.13344

3. Hall WA, Hutton E, Brant RF, et al. A randomized controlled trial of an intervention for infants’ behavioral sleep problems. BMC Pediatr. 2015;15:181. doi:10.1186/s12887-015-0492-7

4. Symon BG, Marley JE, Martin AJ, et al. Effect of a consultation teaching behaviour modification on sleep performance in infants: a randomised controlled trial. Med J Aust. 2005;182:215-218. doi: 10.5694/j.1326-5377.2005.tb06669.x

5. Taveras EM, Blackburn K, Gillman MW, et al. First steps for mommy and me: a pilot intervention to improve nutrition and physical activity behaviors of postpartum mothers and their infants. Matern Child Health J. 2011;15:1217-1227. doi: 10.1007/s10995-010-0696-2

6. Skuladottir A, Thome M, Ramel A. Improving day and night sleep problems in infants by changing day time sleep rhythm: a single group before and after study. Int J Nurs Stud. 2005;42:843-850. doi: 10.1016/j.ijnurstu.2004.12.004

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Do behavioral interventions improve nighttime sleep in children < 1 year old?
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EVIDENCE-BASED ANSWER:

YES. Infants respond to behavioral interventions, although objective data are limited. Behavioral interventions include establishing regular daytime and sleep routines for the infant, reducing environmental noises or distractions, and allowing for self-soothing at bedtime (strength of recommendation: B, based on multiple randomized and nonrandomized studies).

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Long COVID-19 in children and adolescents: What do we know?

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Among scientists, the existence of long COVID-19 in children and adolescents has been the subject of debate. Two published studies have drawn attention to long COVID-19 signs and symptoms in these patients.

Published by a Mexican multidisciplinary group in Scientific Reports, the first study is a systematic review and meta-analysis. It identified mood symptoms as the most prevalent clinical manifestations of long COVID-19 in children and adolescents. These symptoms included sadness, tension, anger, depression, and anxiety (16.50%); fatigue (9.66%); and sleep disorders (8.42%).

The second study, LongCOVIDKidsDK, was conducted in Denmark. It compared 11,000 children younger than 14 years who had tested positive for COVID-19 with 33,000 children who had no history of COVID-19. The study was published in The Lancet Child and Adolescent Health.
 

Definitions are changing

In their meta-analysis, the researchers estimated the prevalence and counted signs and symptoms of long COVID-19, as defined by the United Kingdom’s National Institute for Health and Care Excellence. Long COVID-19 was defined as the presence of one or more symptoms more than 4 weeks after SARS-CoV-2 infection. For search terms, the researchers used “COVID-19,” “COVID,” “SARSCOV-2,” “coronavirus,” “long COVID,” “postCOVID,” “PASC,” “long-haulers,” “prolonged,” “post-acute,” “persistent,” “convalescent,” “sequelae,” and “postviral.”

Of the 8,373 citations returned by the search as of Feb. 10, 2022, 21 prospective studies, 2 of them on preprint servers, met the authors’ selection criteria. Those studies included a total of 80,071 children and adolescents younger than 18 years.

In the meta-analysis, the prevalence of long COVID-19 among children and adolescents was reported to be 25.24% (95% confidence interval, 18.17-33.02; I2, 99.61%), regardless of whether the case had been asymptomatic, mild, moderate, severe, or serious. For patients who had been hospitalized, the prevalence was 29.19% (95% CI, 17.83-41.98; I2, 80.84%).

These numbers, while striking, are not the focus of the study, according to first author Sandra Lopez-Leon, MD, PhD, associate professor of pharmacoepidemiology at Rutgers University, New Brunswick, N.J. “It’s important that we don’t focus on that 25%,” she said in an interview. “It’s a disease that we’re learning about, we’re at a time when the definitions are still changing, and, depending on when it is measured, a different number will be given. The message we want to give is that long COVID-19 exists, it’s happening in children and adolescents, and patients need this recognition. And also to show that it can affect the whole body.”

The study showed that the children and adolescents who presented with SARS-CoV-2 infection were at higher risk of subsequent long dyspnea, anosmia/ageusia, or fever, compared with control persons.

In total, in the studies that were included, more than 40 long-term clinical manifestations associated with COVID-19 in the pediatric population were identified.

The most common symptoms among children aged 0-3 years were mood swings, skin rashes, and stomachaches. In 4- to 11-year-olds, the most common symptoms were mood swings, trouble remembering or concentrating, and skin rashes. In 12- to 14-year-olds, they were fatigue, mood swings, and trouble remembering or concentrating. These data are based on parent responses.

The list of signs and symptoms also includes headache, respiratory symptoms, cognitive symptoms (such as decreased concentration, learning difficulties, confusion, and memory loss), loss of appetite, and smell disorder (hyposmia, anosmia, hyperosmia, parosmia, and phantom smell).

In the studies, the prevalence of the following symptoms was less than 5%: hyperhidrosis, chest pain, dizziness, cough, myalgia/arthralgia, changes in body weight, taste disorder, otalgia (tinnitus, ear pain, vertigo), ophthalmologic symptoms (conjunctivitis, dry eye, blurred vision, photophobia, pain), dermatologic symptoms (dry skin, itchy skin, rashes, hives, hair loss), urinary symptoms, abdominal pain, throat pain, chest tightness, variations in heart rate, palpitations, constipation, dysphonia, fever, diarrhea, vomiting/nausea, menstrual changes, neurological abnormalities, speech disorders, and dysphagia.

The authors made it clear that the frequency and severity of these symptoms can fluctuate from one patient to another.

“The meta-analysis is important because it brings together 21 studies selected from more than 8,000 articles – and in them, a large number of children – to study the most common manifestations of long COVID-19,” Gabriela Ensinck, MD, head of the infectious diseases department at the Víctor J. Vilela Children’s Hospital in Rosario, Argentina, told this news organization. Dr. Ensinck did not participate in the study. “The important thing here is that long COVID-19 exists in pediatrics. And that it is a prolongation of signs or symptoms over time, a time for which there is no single definition.”

“It’s a snapshot of all the symptoms that can remain after COVID-19,” Dr. Lopez-Leon explained. “The meta-analysis seeks to see if there’s an association between having had COVID-19 and having the symptoms, but at no time does it speak of causality.”

The prevalence of symptoms largely depends on the time since the onset of acute COVID-19. Most symptoms improve over time. In the studies that were included in the meta-analysis, the follow-up time varied between 1 and 13 months. It is important to understand what symptoms are associated with each period after the onset of infection, the authors said.
 

 

 

Danish parent survey

The Danish study LongCOVIDKidsDK followed the World Health Organization criteria for long COVID-19 and included children and adolescents aged 0-14 years who received a diagnosis of COVID-19 and who experienced symptoms that lasted at least 2 months.

Between July 20, 2021, and Sept. 15, 2021, a questionnaire was sent to 38,152 case patients and 147,212 control persons. Of this group, 10,997 (28.8%) case patients and 33,016 (22.4%) control persons answered the survey.

Children who had been diagnosed with SARS-CoV-2 infection were more likely to experience long-lasting symptoms than children who had never been diagnosed. Approximately one-third of children with a positive SARS-CoV-2 test experienced symptoms that were not present before infection. Children who experienced long-lasting symptoms included 40% of children diagnosed with COVID-19 and 27% of control persons aged 0-3 years, 38% of case patients and 34% of control persons aged 4-11 years, and 46% of case patients and 41% of control persons aged 12-14 years.

Interestingly, those diagnosed with COVID-19 reported fewer psychological and social problems than those in the control group. Among the oldest (aged 12-14 years), quality of life scores were higher and anxiety scores were lower for those who had tested positive for SARS-CoV-2.
 

More information needed

Given the diversity of symptoms in the meta-analysis and the LongCOVIDKidsDK study, a multidisciplinary approach is imperative. Dr. Lopez-Leon suggests that there is a need to raise awareness among parents, clinicians, researchers, and the health system about the conditions that can occur after COVID-19. Clinicians must better understand the sequelae to provide targeted care and treatment. The authors of the Danish study recommend establishing clinics for long COVID-19 with multispecialty care.

Maren J. Heilskov Rytter, PhD, associate professor of clinical medicine at the University of Copenhagen, wrote an editorial in The Lancet Child and Adolescent Health about the Danish study. Until it is clarified whether SARS-CoV-2 does indeed cause persistent symptoms, she wrote, “it seems excessive and premature to establish specific multidisciplinary clinics for children with long COVID-19.”

Dr. Rytter highlighted the difficulty of interpreting LongCOVIDKidsDK data, owing to recall bias, the failure to exclude other causes of symptoms in the cases analyzed, and the number of symptoms in the control persons. In addition, the data analyzed in Denmark are of limited clinical relevance, she said, given a greater presence of mild symptoms and, paradoxically, a higher quality of life.

She concluded, “In the majority of children with nonspecific symptoms after COVID-19, the symptoms presented are more likely to have been caused by something other than COVID-19, and if they are related to COVID-19, they are likely to go away over time.”

Dr. Ensinck, who is coauthor of the Argentine Ministry of Health’s guide for long COVID-19 monitoring for children and adolescents and who represented the Infectious Diseases Committee of the Argentine Society of Pediatrics, highlighted another aspect of the problem. “What should be taken into account in these data is to see how much the confinement contributed. Children are the ones who suffered the most in the period in which schools were closed; they could not meet their peers, they had sick relatives, they felt fear. … all this must be taken into account.”

There is as yet no agreement on how to define and diagnose long COVID-19 in adults, a population that has been studied more closely. Part of the problem is that long COVID-19 has been linked to more than 200 symptoms, which can range in severity from inconvenient to debilitating, can last for months or years, and can recur, sometimes months after apparent recovery. Thus, there are still disparate answers to basic questions about the syndrome’s frequency and its effects on vaccination, reinfection, and the latest variant of SARS-CoV-2.

This article has been translated from the Medscape Spanish edition. A version appeared on Medscape.com.

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Among scientists, the existence of long COVID-19 in children and adolescents has been the subject of debate. Two published studies have drawn attention to long COVID-19 signs and symptoms in these patients.

Published by a Mexican multidisciplinary group in Scientific Reports, the first study is a systematic review and meta-analysis. It identified mood symptoms as the most prevalent clinical manifestations of long COVID-19 in children and adolescents. These symptoms included sadness, tension, anger, depression, and anxiety (16.50%); fatigue (9.66%); and sleep disorders (8.42%).

The second study, LongCOVIDKidsDK, was conducted in Denmark. It compared 11,000 children younger than 14 years who had tested positive for COVID-19 with 33,000 children who had no history of COVID-19. The study was published in The Lancet Child and Adolescent Health.
 

Definitions are changing

In their meta-analysis, the researchers estimated the prevalence and counted signs and symptoms of long COVID-19, as defined by the United Kingdom’s National Institute for Health and Care Excellence. Long COVID-19 was defined as the presence of one or more symptoms more than 4 weeks after SARS-CoV-2 infection. For search terms, the researchers used “COVID-19,” “COVID,” “SARSCOV-2,” “coronavirus,” “long COVID,” “postCOVID,” “PASC,” “long-haulers,” “prolonged,” “post-acute,” “persistent,” “convalescent,” “sequelae,” and “postviral.”

Of the 8,373 citations returned by the search as of Feb. 10, 2022, 21 prospective studies, 2 of them on preprint servers, met the authors’ selection criteria. Those studies included a total of 80,071 children and adolescents younger than 18 years.

In the meta-analysis, the prevalence of long COVID-19 among children and adolescents was reported to be 25.24% (95% confidence interval, 18.17-33.02; I2, 99.61%), regardless of whether the case had been asymptomatic, mild, moderate, severe, or serious. For patients who had been hospitalized, the prevalence was 29.19% (95% CI, 17.83-41.98; I2, 80.84%).

These numbers, while striking, are not the focus of the study, according to first author Sandra Lopez-Leon, MD, PhD, associate professor of pharmacoepidemiology at Rutgers University, New Brunswick, N.J. “It’s important that we don’t focus on that 25%,” she said in an interview. “It’s a disease that we’re learning about, we’re at a time when the definitions are still changing, and, depending on when it is measured, a different number will be given. The message we want to give is that long COVID-19 exists, it’s happening in children and adolescents, and patients need this recognition. And also to show that it can affect the whole body.”

The study showed that the children and adolescents who presented with SARS-CoV-2 infection were at higher risk of subsequent long dyspnea, anosmia/ageusia, or fever, compared with control persons.

In total, in the studies that were included, more than 40 long-term clinical manifestations associated with COVID-19 in the pediatric population were identified.

The most common symptoms among children aged 0-3 years were mood swings, skin rashes, and stomachaches. In 4- to 11-year-olds, the most common symptoms were mood swings, trouble remembering or concentrating, and skin rashes. In 12- to 14-year-olds, they were fatigue, mood swings, and trouble remembering or concentrating. These data are based on parent responses.

The list of signs and symptoms also includes headache, respiratory symptoms, cognitive symptoms (such as decreased concentration, learning difficulties, confusion, and memory loss), loss of appetite, and smell disorder (hyposmia, anosmia, hyperosmia, parosmia, and phantom smell).

In the studies, the prevalence of the following symptoms was less than 5%: hyperhidrosis, chest pain, dizziness, cough, myalgia/arthralgia, changes in body weight, taste disorder, otalgia (tinnitus, ear pain, vertigo), ophthalmologic symptoms (conjunctivitis, dry eye, blurred vision, photophobia, pain), dermatologic symptoms (dry skin, itchy skin, rashes, hives, hair loss), urinary symptoms, abdominal pain, throat pain, chest tightness, variations in heart rate, palpitations, constipation, dysphonia, fever, diarrhea, vomiting/nausea, menstrual changes, neurological abnormalities, speech disorders, and dysphagia.

The authors made it clear that the frequency and severity of these symptoms can fluctuate from one patient to another.

“The meta-analysis is important because it brings together 21 studies selected from more than 8,000 articles – and in them, a large number of children – to study the most common manifestations of long COVID-19,” Gabriela Ensinck, MD, head of the infectious diseases department at the Víctor J. Vilela Children’s Hospital in Rosario, Argentina, told this news organization. Dr. Ensinck did not participate in the study. “The important thing here is that long COVID-19 exists in pediatrics. And that it is a prolongation of signs or symptoms over time, a time for which there is no single definition.”

“It’s a snapshot of all the symptoms that can remain after COVID-19,” Dr. Lopez-Leon explained. “The meta-analysis seeks to see if there’s an association between having had COVID-19 and having the symptoms, but at no time does it speak of causality.”

The prevalence of symptoms largely depends on the time since the onset of acute COVID-19. Most symptoms improve over time. In the studies that were included in the meta-analysis, the follow-up time varied between 1 and 13 months. It is important to understand what symptoms are associated with each period after the onset of infection, the authors said.
 

 

 

Danish parent survey

The Danish study LongCOVIDKidsDK followed the World Health Organization criteria for long COVID-19 and included children and adolescents aged 0-14 years who received a diagnosis of COVID-19 and who experienced symptoms that lasted at least 2 months.

Between July 20, 2021, and Sept. 15, 2021, a questionnaire was sent to 38,152 case patients and 147,212 control persons. Of this group, 10,997 (28.8%) case patients and 33,016 (22.4%) control persons answered the survey.

Children who had been diagnosed with SARS-CoV-2 infection were more likely to experience long-lasting symptoms than children who had never been diagnosed. Approximately one-third of children with a positive SARS-CoV-2 test experienced symptoms that were not present before infection. Children who experienced long-lasting symptoms included 40% of children diagnosed with COVID-19 and 27% of control persons aged 0-3 years, 38% of case patients and 34% of control persons aged 4-11 years, and 46% of case patients and 41% of control persons aged 12-14 years.

Interestingly, those diagnosed with COVID-19 reported fewer psychological and social problems than those in the control group. Among the oldest (aged 12-14 years), quality of life scores were higher and anxiety scores were lower for those who had tested positive for SARS-CoV-2.
 

More information needed

Given the diversity of symptoms in the meta-analysis and the LongCOVIDKidsDK study, a multidisciplinary approach is imperative. Dr. Lopez-Leon suggests that there is a need to raise awareness among parents, clinicians, researchers, and the health system about the conditions that can occur after COVID-19. Clinicians must better understand the sequelae to provide targeted care and treatment. The authors of the Danish study recommend establishing clinics for long COVID-19 with multispecialty care.

Maren J. Heilskov Rytter, PhD, associate professor of clinical medicine at the University of Copenhagen, wrote an editorial in The Lancet Child and Adolescent Health about the Danish study. Until it is clarified whether SARS-CoV-2 does indeed cause persistent symptoms, she wrote, “it seems excessive and premature to establish specific multidisciplinary clinics for children with long COVID-19.”

Dr. Rytter highlighted the difficulty of interpreting LongCOVIDKidsDK data, owing to recall bias, the failure to exclude other causes of symptoms in the cases analyzed, and the number of symptoms in the control persons. In addition, the data analyzed in Denmark are of limited clinical relevance, she said, given a greater presence of mild symptoms and, paradoxically, a higher quality of life.

She concluded, “In the majority of children with nonspecific symptoms after COVID-19, the symptoms presented are more likely to have been caused by something other than COVID-19, and if they are related to COVID-19, they are likely to go away over time.”

Dr. Ensinck, who is coauthor of the Argentine Ministry of Health’s guide for long COVID-19 monitoring for children and adolescents and who represented the Infectious Diseases Committee of the Argentine Society of Pediatrics, highlighted another aspect of the problem. “What should be taken into account in these data is to see how much the confinement contributed. Children are the ones who suffered the most in the period in which schools were closed; they could not meet their peers, they had sick relatives, they felt fear. … all this must be taken into account.”

There is as yet no agreement on how to define and diagnose long COVID-19 in adults, a population that has been studied more closely. Part of the problem is that long COVID-19 has been linked to more than 200 symptoms, which can range in severity from inconvenient to debilitating, can last for months or years, and can recur, sometimes months after apparent recovery. Thus, there are still disparate answers to basic questions about the syndrome’s frequency and its effects on vaccination, reinfection, and the latest variant of SARS-CoV-2.

This article has been translated from the Medscape Spanish edition. A version appeared on Medscape.com.

Among scientists, the existence of long COVID-19 in children and adolescents has been the subject of debate. Two published studies have drawn attention to long COVID-19 signs and symptoms in these patients.

Published by a Mexican multidisciplinary group in Scientific Reports, the first study is a systematic review and meta-analysis. It identified mood symptoms as the most prevalent clinical manifestations of long COVID-19 in children and adolescents. These symptoms included sadness, tension, anger, depression, and anxiety (16.50%); fatigue (9.66%); and sleep disorders (8.42%).

The second study, LongCOVIDKidsDK, was conducted in Denmark. It compared 11,000 children younger than 14 years who had tested positive for COVID-19 with 33,000 children who had no history of COVID-19. The study was published in The Lancet Child and Adolescent Health.
 

Definitions are changing

In their meta-analysis, the researchers estimated the prevalence and counted signs and symptoms of long COVID-19, as defined by the United Kingdom’s National Institute for Health and Care Excellence. Long COVID-19 was defined as the presence of one or more symptoms more than 4 weeks after SARS-CoV-2 infection. For search terms, the researchers used “COVID-19,” “COVID,” “SARSCOV-2,” “coronavirus,” “long COVID,” “postCOVID,” “PASC,” “long-haulers,” “prolonged,” “post-acute,” “persistent,” “convalescent,” “sequelae,” and “postviral.”

Of the 8,373 citations returned by the search as of Feb. 10, 2022, 21 prospective studies, 2 of them on preprint servers, met the authors’ selection criteria. Those studies included a total of 80,071 children and adolescents younger than 18 years.

In the meta-analysis, the prevalence of long COVID-19 among children and adolescents was reported to be 25.24% (95% confidence interval, 18.17-33.02; I2, 99.61%), regardless of whether the case had been asymptomatic, mild, moderate, severe, or serious. For patients who had been hospitalized, the prevalence was 29.19% (95% CI, 17.83-41.98; I2, 80.84%).

These numbers, while striking, are not the focus of the study, according to first author Sandra Lopez-Leon, MD, PhD, associate professor of pharmacoepidemiology at Rutgers University, New Brunswick, N.J. “It’s important that we don’t focus on that 25%,” she said in an interview. “It’s a disease that we’re learning about, we’re at a time when the definitions are still changing, and, depending on when it is measured, a different number will be given. The message we want to give is that long COVID-19 exists, it’s happening in children and adolescents, and patients need this recognition. And also to show that it can affect the whole body.”

The study showed that the children and adolescents who presented with SARS-CoV-2 infection were at higher risk of subsequent long dyspnea, anosmia/ageusia, or fever, compared with control persons.

In total, in the studies that were included, more than 40 long-term clinical manifestations associated with COVID-19 in the pediatric population were identified.

The most common symptoms among children aged 0-3 years were mood swings, skin rashes, and stomachaches. In 4- to 11-year-olds, the most common symptoms were mood swings, trouble remembering or concentrating, and skin rashes. In 12- to 14-year-olds, they were fatigue, mood swings, and trouble remembering or concentrating. These data are based on parent responses.

The list of signs and symptoms also includes headache, respiratory symptoms, cognitive symptoms (such as decreased concentration, learning difficulties, confusion, and memory loss), loss of appetite, and smell disorder (hyposmia, anosmia, hyperosmia, parosmia, and phantom smell).

In the studies, the prevalence of the following symptoms was less than 5%: hyperhidrosis, chest pain, dizziness, cough, myalgia/arthralgia, changes in body weight, taste disorder, otalgia (tinnitus, ear pain, vertigo), ophthalmologic symptoms (conjunctivitis, dry eye, blurred vision, photophobia, pain), dermatologic symptoms (dry skin, itchy skin, rashes, hives, hair loss), urinary symptoms, abdominal pain, throat pain, chest tightness, variations in heart rate, palpitations, constipation, dysphonia, fever, diarrhea, vomiting/nausea, menstrual changes, neurological abnormalities, speech disorders, and dysphagia.

The authors made it clear that the frequency and severity of these symptoms can fluctuate from one patient to another.

“The meta-analysis is important because it brings together 21 studies selected from more than 8,000 articles – and in them, a large number of children – to study the most common manifestations of long COVID-19,” Gabriela Ensinck, MD, head of the infectious diseases department at the Víctor J. Vilela Children’s Hospital in Rosario, Argentina, told this news organization. Dr. Ensinck did not participate in the study. “The important thing here is that long COVID-19 exists in pediatrics. And that it is a prolongation of signs or symptoms over time, a time for which there is no single definition.”

“It’s a snapshot of all the symptoms that can remain after COVID-19,” Dr. Lopez-Leon explained. “The meta-analysis seeks to see if there’s an association between having had COVID-19 and having the symptoms, but at no time does it speak of causality.”

The prevalence of symptoms largely depends on the time since the onset of acute COVID-19. Most symptoms improve over time. In the studies that were included in the meta-analysis, the follow-up time varied between 1 and 13 months. It is important to understand what symptoms are associated with each period after the onset of infection, the authors said.
 

 

 

Danish parent survey

The Danish study LongCOVIDKidsDK followed the World Health Organization criteria for long COVID-19 and included children and adolescents aged 0-14 years who received a diagnosis of COVID-19 and who experienced symptoms that lasted at least 2 months.

Between July 20, 2021, and Sept. 15, 2021, a questionnaire was sent to 38,152 case patients and 147,212 control persons. Of this group, 10,997 (28.8%) case patients and 33,016 (22.4%) control persons answered the survey.

Children who had been diagnosed with SARS-CoV-2 infection were more likely to experience long-lasting symptoms than children who had never been diagnosed. Approximately one-third of children with a positive SARS-CoV-2 test experienced symptoms that were not present before infection. Children who experienced long-lasting symptoms included 40% of children diagnosed with COVID-19 and 27% of control persons aged 0-3 years, 38% of case patients and 34% of control persons aged 4-11 years, and 46% of case patients and 41% of control persons aged 12-14 years.

Interestingly, those diagnosed with COVID-19 reported fewer psychological and social problems than those in the control group. Among the oldest (aged 12-14 years), quality of life scores were higher and anxiety scores were lower for those who had tested positive for SARS-CoV-2.
 

More information needed

Given the diversity of symptoms in the meta-analysis and the LongCOVIDKidsDK study, a multidisciplinary approach is imperative. Dr. Lopez-Leon suggests that there is a need to raise awareness among parents, clinicians, researchers, and the health system about the conditions that can occur after COVID-19. Clinicians must better understand the sequelae to provide targeted care and treatment. The authors of the Danish study recommend establishing clinics for long COVID-19 with multispecialty care.

Maren J. Heilskov Rytter, PhD, associate professor of clinical medicine at the University of Copenhagen, wrote an editorial in The Lancet Child and Adolescent Health about the Danish study. Until it is clarified whether SARS-CoV-2 does indeed cause persistent symptoms, she wrote, “it seems excessive and premature to establish specific multidisciplinary clinics for children with long COVID-19.”

Dr. Rytter highlighted the difficulty of interpreting LongCOVIDKidsDK data, owing to recall bias, the failure to exclude other causes of symptoms in the cases analyzed, and the number of symptoms in the control persons. In addition, the data analyzed in Denmark are of limited clinical relevance, she said, given a greater presence of mild symptoms and, paradoxically, a higher quality of life.

She concluded, “In the majority of children with nonspecific symptoms after COVID-19, the symptoms presented are more likely to have been caused by something other than COVID-19, and if they are related to COVID-19, they are likely to go away over time.”

Dr. Ensinck, who is coauthor of the Argentine Ministry of Health’s guide for long COVID-19 monitoring for children and adolescents and who represented the Infectious Diseases Committee of the Argentine Society of Pediatrics, highlighted another aspect of the problem. “What should be taken into account in these data is to see how much the confinement contributed. Children are the ones who suffered the most in the period in which schools were closed; they could not meet their peers, they had sick relatives, they felt fear. … all this must be taken into account.”

There is as yet no agreement on how to define and diagnose long COVID-19 in adults, a population that has been studied more closely. Part of the problem is that long COVID-19 has been linked to more than 200 symptoms, which can range in severity from inconvenient to debilitating, can last for months or years, and can recur, sometimes months after apparent recovery. Thus, there are still disparate answers to basic questions about the syndrome’s frequency and its effects on vaccination, reinfection, and the latest variant of SARS-CoV-2.

This article has been translated from the Medscape Spanish edition. A version appeared on Medscape.com.

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Eczema causes substantial burden for many infants and preschoolers

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Tue, 07/12/2022 - 07:36

 

Infants and preschoolers with atopic dermatitis (AD) experience a substantial disease burden across several domains, including atopic comorbidities, pruritus, sleep loss, hospitalizations, frequent prolonged flares, and school attendance. Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.

For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.

AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.

The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.



More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.

In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.

Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”

The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.

Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.

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Infants and preschoolers with atopic dermatitis (AD) experience a substantial disease burden across several domains, including atopic comorbidities, pruritus, sleep loss, hospitalizations, frequent prolonged flares, and school attendance. Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.

For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.

AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.

The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.



More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.

In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.

Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”

The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.

Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.

 

Infants and preschoolers with atopic dermatitis (AD) experience a substantial disease burden across several domains, including atopic comorbidities, pruritus, sleep loss, hospitalizations, frequent prolonged flares, and school attendance. Those are key findings from a large international web-based survey that was presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

“Improved knowledge of the AD-related burden may help reinforce the medical need in the pediatric population and contribute to better and earlier adequate management of the disease,” authors led by Stephan Weidinger , MD, PhD, vice head of the department of dermatology at University Hospital Schleswig-Holstein, Kiel, Germany, wrote in the abstract.

For the study, Dr. Weidinger and colleagues evaluated 1,486 infants and preschoolers with AD aged 6 months to under 6 years, who participated in the Epidemiology of Children with Atopic Dermatitis Reporting on their Experience (EPI-CARE), an international, cross-sectional, web-based survey of children and adolescents. The study population resided in 18 countries from five regions of the world, including North America, Latin America, Europe, Middle East/Eurasia, and East Asia. Parents or guardians answered all questions for infants/preschoolers younger than 4 years of age, while preschoolers aged 4 to younger than 6 years were asked to answer questions related to the impact of AD on their health-related quality of life.

AD severity was assessed using Patient Global Assessment (PtGA), where parents or guardians described their child’s eczema severity over the last week as mild, moderate, or severe. The researchers stratified outcomes by geographic region and AD severity, which included the following atopic comorbidities: worst itch, worst skin pain, and overall sleep disturbance in the past 24 hours as measured by the 0-10 numeric rating scale, where higher scores indicate worse severity; eczema-related hospitalization in the past 12 months; and frequency and average duration of flares over the past month.

The mean age of the study participants was 3 years and 61.6% had mild disease. The most common atopic comorbidities were hay fever, asthma, and seasonal allergies, and the incidence of atopic comorbidities increased with increasing AD severity. One or more atopic comorbidities was reported in 88.3% of patients with mild AD, compared with 92.1% of those with moderate disease and 95.8% of those with severe disease. In addition, infants and preschoolers with moderate or severe AD had worse itch, skin pain, and sleep disturbances over the past 24 hours, compared with those who had mild AD.



More than half of infants and preschoolers with severe AD (54.1%) were reported to have been hospitalized in the past 12 months (this ranged from 30.2% to 71.3% across regions), as did 35% of patients with moderate AD and 32.1% of those with mild AD. In addition, 50.6% of infants and preschoolers with severe AD had more than two flares in the past month, compared with 18.1% of those with moderate AD and 6.3% of those with mild disease.

In other findings, 50.7% of infants and preschoolers with severe AD had flares than lasted an average of 2 or more weeks, compared with 20.8% of those with moderate disease and 10% of those with mild disease. Also, 78.3% of preschoolers aged 4 to less than 6 years had missed one or more days of school in the previous 4 weeks: a mean of 5.1 days among those with mild AD, a mean of 7.3 days among those with moderate AD, and a mean of 12.1 days among those with severe disease.

Raj J. Chovatiya MD, PhD, of the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study, said that infants and preschoolers remain an understudied group despite the high prevalence of AD in this age range. “The results of this study demonstrate a substantial burden of disease in this population, particularly among those with more severe disease,” said Dr. Chovatiya, who also directs the university’s Center for Eczema and Itch. “This includes longer and more frequent AD flares as well as high rates of inpatient hospitalization. These findings suggest that additional research is needed to better characterize disease burden and optimize outcomes for young children with AD.”

The study was funded by Regeneron Pharmaceuticals and Sanofi. Dr. Weidinger and other coauthors reported having received institutional research grants and consulting fees from many pharmaceutical companies that manufacture drugs used for the treatment of psoriasis and eczema.

Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, L’Oréal, the National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB.

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